31976 Federal Register Vol 82 No 131 Tuesday July 11 -Books Pdf

31976 Federal Register Vol 82 No 131 Tuesday July 11
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Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices 31977. III Limitations on Exemptions limit the exemption from premarket exemptions found in 862 9 to 892 9. notification requirements to specific In table 2 for example FDA is listing. FDA believes that the types of class II devices within a listed device type In the exemption of the tympanometer but. devices listed in this notice should be such situations where a partial limits the exemption to such devices. exempt from the premarket notification exemption limitation has been that are in compliance with FDA. requirements found under section identified FDA has determined that recognized consensus standard ANSI. 510 k of the FD C Act However an premarket notification is necessary to S3 39 Tympanometers that comply. exemption from the requirement of provide a reasonable assurance of safety. premarket notification does not mean with this partial exemption limitation. and effectiveness for these devices and the corresponding general. that the device is exempt from any other Partial exemption limitations can be. statutory or regulatory requirements limitations in 874 9 are now exempt. found in table 2 of this notice FDA has from the 510 k requirements and. unless such exemption is explicitly assigned new product codes to the. provided by order or regulation FDA s should be identified under new product. device types that are now exempt code PTP in subsequent registration. determination that premarket subject to the partial limitations in order. notification is unnecessary to provide a and listing submissions However. to ensure that these devices can be tympanometers not in compliance with. reasonable assurance of safety and separated from devices that do not fall. effectiveness for devices listed in this each of these exemption limitations. within the partial exemption limitation, document is based in part on the remain subject to the 510 k. under the existing product code i e, assurance of safety and effectiveness requirements and will retain product. exempt and non exempt devices within, that other regulatory controls such as code NAS We recommend that. a device type will have distinct product, current good manufacturing practice codes If table 2 indicates that a partial device manufacturers document in their. requirements provide exemption limitation does apply to a records any changes in the product code. In addition to being subject to the device then affected device of their device with appropriate. general limitations to the exemptions manufacturers should review their justification. found in Title 21 of the Code of Federal registration and listing information to IV List of Class II Devices. Regulations CFR sections 862 9 to assess if they should list their device. 892 9 862 9 to 892 9 when Agency using the original classification product In table 1 FDA is identifying the. assessment determines that the factors code which requires premarket following list of class II devices that no. laid out in the Class II 510 k Exemption notification or the new classification longer require premarket notification. Guidance Ref 1 do not weigh in favor product code for the subset of that under section 510 k of the FD C Act. of exemption for all devices in a device type that is now 510 k exempt subject to the general limitations to the. particular group FDA may partially subject to the general limitations to the exemptions found in 862 9 to 892 9. TABLE 1 CLASS II DEVICES,21 CFR section Device type code.
862 1020 Acid Phosphatase Nitrophenylphosphate CJN. 862 1020 Acid Phosphatase Thymol Blue Monophosphate CJR. 862 1020 Acid Phosphatase Disodium Phenylphosphate CJX. 862 1020 Acid Phosphatase Naphthyl Phosphate CKB, 862 1020 Acid Phosphatase Thymolphthale Inmonophosphate CKE. 862 1020 Acid Phosphatase Beta Glycerophosphate CKH. 862 1020 Acid Phosphatase Prostatic Tartrate Inhibited JFH. 862 1090 Radioassay Angiotensin Converting Enzyme KQN. 862 1100 Vanillin Pyruvate AST SGOT CIF,862 1100 Diazo AST SGOT CIQ. 862 1100 Hydrazone Colorimetry AST SGOT CIS, 862 1100 NADH Oxidation NAD Reduction AST SGOT CIT. 862 1150 Calibrator Primary JIS,862 1150 Calibrator Secondary JIT. 862 1150 Calibrator Surrogate JIW,862 1150 Calibrator Multi Analyte Mixture JIX.
862 1345 Drink Glucose Tolerance MRV, 862 1350 Continuous Glucose Monitor Secondary Display PJT. 862 1445 Chromatographic Separation Lactate Dehydrogenase Isoenzymes CEX. 862 1445 Electrophoretic Lactate Dehydrogenase Isoenzymes CFE. 862 1445 Differential Rate Kinetic Method Lactate Dehydrogenase Isoenzymes JGF. 862 1509 System Test Urinary Methylmalonic Acid LPT. 862 1685 Radioimmunoassay Thyroxine Binding Globulin CEE. 862 1700 Radioimmunoassay Total Thyroxine CDX, 862 1700 Enzyme Immunoassay Non Radiolabeled Total Thyroxine KLI. 862 2265 High Throughput DNA Sequence Analyzer PFF. 862 2570 Instrumentation For Clinical Multiplex Test Systems NSU. mstockstill on DSK30JT082PROD with NOTICES, 862 2570 Real Time Nucleic Acid Amplification System OOI. 862 2570 Mass Spectrometer For Clinical Multiplex Test Systems OTA. 862 2570 Micro Total Analysis Instrument System OUE. 862 2570 Complete Gene Expression Profiling Accessory Reagents OVA. 862 2570 DNA Genetic Analyzer PCA,862 2570 Data Acquisition Software PQQ. 862 3200 Calibrators Drug Mixture DKB,862 3200 Calibrators Drug Specific DLJ.
VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. 31978 Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices. TABLE 1 CLASS II DEVICES Continued,21 CFR section Device type code. 862 3200 Calibrators Ethyl Alcohol DNN,864 5400 Fibrometer GIE. 864 5400 Timer Coagulation JBT,864 5425 Control Plasma Abnormal GGC. 864 5425 Plasma Coagulation Control GGN,864 5425 Plasma Control Normal GIZ. 864 6550 Control Fecal Occult Blood OSL,864 6650 Study Platelet Adhesive JBZ.
864 7275 Test Euglobulin Lysis JBO,864 7300 Fibrin Monomer Paracoagulation JBN. 864 7340 Fibrinogen Standard GFX,864 7340 Plasma Fibrinogen Control GIL. 864 7375 Glutathione Red Cell GII, 864 7375 Fluorescence Visual Observation Qual U V Glutathione Reductase JMH. 864 7375 Assay Glutathione Reductase KQF,864 7415 Control Hemoglobin Abnormal JCM. 864 7455 Stain Fetal Hemoglobin GHQ,864 7500 Acid Hematin GGF.
864 7720 Test Prothrombin Consumption GGQ, 864 7735 Prothrombin Proconvertin and Thrombotest JPF. 864 8150 Calibrator for Cell Indices KRX, 864 8165 Calibrator for Hemoglobin and Hematocrit Measurement KRZ. 864 8175 Calibrator for Platelet Counting KRY, 864 8185 Calibrator for Red Cell and White Cell Counting KSA. 864 8625 Standards and Controls Hemoglobin Normal and Abnormal GFS. 864 8625 Control White Cell GGL,864 8625 Control Hemoglobin GGM. 864 8625 Control Platelet GJP,864 8625 Control Red Cell GJR.
864 8625 Control Hematocrit GLK, 864 8625 Mixture Control White Cell and Red Cell Indices GLQ. 864 8625 Control Cell Counter Normal and Abnormal JCN. 864 8625 Mixture Hematology Quality Control JPK, 864 8625 Material Quality Control Semen Analysis NRF. 864 8625 Control Material Blood Circulating Epithelial Cancer Cell NRS. 864 9400 Solution Stabilized Enzyme KSK,866 3395 Norovirus Serological Reagents OUC. 866 5210 Immunochemical Ceruloplasmin CHN, 866 5210 Ceruloplasmin Rhodamine Antigen Antiserum Control DCT. 866 5210 Ceruloplasmin FITC Antigen Antiserum Control DCY. 866 5210 Ceruloplasmin Antigen Antiserum Control DDB. 866 5210 P Phenyl Enediamine EDTA Spectrophotometric Ceruloplasmin JFQ. 866 5210 Indirect Copper Assay Ceruloplasmin JFR, 866 5470 Hemoglobin Chain Specific Antigen Antiserum Control DAM.
866 5620 Alpha 2 Macroglobulin Rhodamine Antigen Antiserum Control DDT. 866 5620 Alpha 2 Macroglobulin FITC Antigen Antiserum Control DDY. 866 5620 Alpha 2 Macroglobulin Antigen Antiserum Control DEB. 866 5630 System Test Beta 2 Microglobulin Immunological JZG. 866 5910 Quality Control Material Genetics DNA NZB. 868 1040 Algesimeter Powered BSI,868 1400 Legging Compression Non Inflatable LLK. 868 2500 Monitor Oxygen Cutaneous For Infant Not Under Gas Anesthesia KLK. 868 2500 Monitor Oxygen Cutaneous For Uses Other Than For Infant Not Under Gas Anesthesia LPP. 868 2550 Pneumotachometer JAX,868 5180 Bed Rocking Breathing Assist CCO. 868 6250 Compressor Air Portable BTI,870 1390 Trocar DRC. 870 1875 Lung Sound Monitor OCR,870 2675 Oscillometer DRZ. 870 4280 Filter Prebypass Cardiopulmonary Bypass KRJ. 870 4290 Adaptor Stopcock Manifold Fitting Cardiopulmonary Bypass DTL. 870 4340 Monitor and or Control Level Sensing Cardiopulmonary Bypass DTW. 870 4420 Sucker Cardiotomy Return Cardiopulmonary Bypass DTS. mstockstill on DSK30JT082PROD with NOTICES, 870 4430 Suction Control Intracardiac Cardiopulmonary Bypass DWD.
872 1720 Tester Pulp EAT,872 3260 External Cleaning Solution PME. 872 3300 Coating Denture Hydrophilic Resin EBE,872 3540 Pad Denture Over The Counter EHR. 872 3540 Cushion Denture Over The Counter EHS,872 3560 Reliner Denture Over The Counter EBP. 872 3590 Denture Plastic Tooth ELM, VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices 31979. TABLE 1 CLASS II DEVICES Continued,21 CFR section Device type code.
872 3600 Denture Preformed Partially Prefabricated Denture EKO. 872 3890 Splint Endodontic Stabilizing ELS,872 5550 Ring Teething Fluid Filled KKO. 872 6770 Syringe Cartridge EJI, 874 1120 Generator Electronic Noise for Audiometric Testing ETS. 874 1325 Electroglottograph KLX, 874 3310 Calibrator Hearing Aid Earphone and Analysis Systems ETW. 874 3320 Hearing Aid Group and Auditory Trainer EPF. 874 3320 Device Assistive Listening LZI,874 3330 Hearing Aid Master KHL. 874 3430 Mold Middle Ear ETC,874 3730 Device Voice Amplification MCK.
876 1500 Light Source Incandescent Diagnostic FCQ,876 1500 Light Source Photographic Fiberoptic FCR. 876 1500 Light Source Fiberoptic Routine FCW,876 1500 Carrier Sponge Endoscopic FGS. 876 1500 Light Source Endoscope Xenon Arc GCT,876 1500 Transformer Endoscope GCW. 876 1500 LED Light Source NTN, 876 1500 Endoscopic Guide Wire Gastroenterology Urology OCY. 876 4020 Light Catheter Fiberoptic Glass Ureteral FCS. 876 4270 Rod Colostomy EZP,876 4400 Ligator Hemorrhoidal FHN.
876 4400 Ligator Esophageal MND,876 4500 Lithotriptor Biliary Mechanical LQC. 876 4770 Urethrotome EZO,876 5010 Bag Bile Collecting EXF. 876 5025 Vibrator for Climax Control of Premature Ejaculation PIA. 876 5365 Dilator Esophageal Metal Olive Gastro Urology EZM. 876 5365 Bougie Esophageal and Gastrointestinal Gastro Urology FAT. 876 5365 Dilator Esophageal KNQ,876 5520 Dilator Urethral KOE. 876 5665 Disinfectant Subsystem Water Purification NIH. 876 5820 Set Dialyzer Holder FKI,876 5895 Irrigator Ostomy EXD. 876 5980 Catheter Retention Barium Enema With Bag FGD. 876 5980 Gastrostomy Tube Holder PLI,878 4370 Drape Surgical ENT ERY.
878 4370 Drape Pure Latex Sheet With Self Retaining Finger Cot EYX. 878 4370 Drape Urological Disposable EYY,878 4370 Pad Kelly FNW. 878 4370 Drape Patient Ophthalmic HMT,878 4370 Drape Microscope Ophthalmic HMW. 878 4370 Ring Wound Protector Drape Retention Internal KGW. 878 4580 Lamp Operating Room FQP,878 4580 Light Surgical Instrument FSQ. 878 4580 Light Surgical Floor Standing FSS,878 4580 Light Surgical Endoscopic FSW. 878 4580 Light Surgical Connector FSX,878 4580 Light Surgical Ceiling Mounted FSY.
878 4580 Light Surgical Carrier FSZ,878 4580 Light Surgical Accessories FTA. 878 4580 Lamp Surgical FTD,878 4580 Illuminator Remote FTG. 878 4580 Lamp Surgical Incandescent GBC,878 5070 Apparatus Air Handling Bench FZG. 878 5070 Apparatus Air Handling Room FZH,878 5070 Apparatus Air Handling Enclosure FZI. 880 5580 Locator Acupuncture Point BWJ,880 5580 Needle Acupuncture Single Use MQX.
880 5780 Stocking Medical Support to Prevent Pooling of Blood in Legs DWL. 882 1020 Analyzer Rigidity GZM, 882 1540 Device Galvanic Skin Response Measurement GZO. mstockstill on DSK30JT082PROD with NOTICES,882 1560 Device Skin Potential Measurement HCJ. 882 1855 Encephalogram Telemetry System GYE,882 5895 Vibratory Counter Stimulation OVP. 884 2990 Sheet Recording Breast Examination NHM,884 3200 Drain Cervical HFL. 884 4400 Forceps Obstetrical HDA,884 4530 Clamp Umbilical HFW.
884 4530 Speculum Vaginal Nonmetal HIB, VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. 31980 Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices. TABLE 1 CLASS II DEVICES Continued,21 CFR section Device type code. 884 4530 Speculum Vaginal Nonmetal Fiberoptic HIC,884 4530 Clamp and Cutter Umbilical NBZ. 884 4900 Table Obstetrical AC Powered and Accessories HDD. 884 4900 Table Obstetrical Manual and Accessories HHP. 884 4900 Table Obstetric and Accessories KNC,884 5200 Hemorrhoid Prevention Pressure Wedge OOA. 884 5390 Heater Perineal Direct Contact HGZ,884 5390 Heater Perineal Radiant Non Contact HHA.
884 5390 Heater Perineal KND,884 5400 Cup Menstrual HHE. 884 5425 Pad Menstrual Scented HHL, 884 6150 Micromanipulators and Microinjectors Assisted Reproduction MQJ. 886 1120 Photorefractor MMF,886 1120 Camera Ophthalmic General Use PJZ. 886 1250 Euthyscope AC Powered HMK,886 1570 Ophthalmoscope AC Powered HLI. 886 1570 Ophthalmoscope Battery Powered HLJ, 886 1570 Ophthalmoscopes Replacement Batteries Hand Held MSG.
886 1780 Retinoscope AC Powered HKL,886 1945 Transilluminator AC Powered HJM. 886 4150 Tubing Replacement Phacofragmentation Unit MSR. 886 4250 Unit Electrolysis AC Powered Ophthalmic HRO. 886 4335 Headlight Fiberoptic Focusing FCT,886 4335 Light Headband Surgical FSR. 886 4335 Headlamp Operating AC Powered HPQ,886 4400 Locator Metal Electronic HPM. 886 4440 Magnet AC Powered HPO,886 4790 Sponge Ophthalmic HOZ. 886 4790 Eye Tray OJK,888 1240 Dynamometer AC Powered LBB.
888 4580 Instrument Surgical Sonic and Accessory Attachment JDX. 888 4580 System Cement Removal Extraction LZV,890 1450 Hammer Reflex Powered IKO. 890 5100 Bath Hydro Massage ILJ,890 5100 Bath Sitz Powered ILM. 890 5110 Bath Paraffin IMC,890 5250 Cabinet Moist Steam IMB. 890 5360 Exerciser Measuring ISD,890 5500 Lamp Infrared Therapeutic Heating ILY. 890 5575 Device Warning Overload External Limb Powered IRN. 892 1000 MRI Disposable Kit OIM,892 1560 Biopsy Needle Guide Kit OIJ.
892 1610 Aperature Radiographic IZS,892 1610 Cone Radiographic IZT. 892 1610 Collimator Automatic Radiographic IZW,892 1610 Collimator Manual Radiographic IZX. 892 1610 Device Beam Limiting X Ray Diagnostic KPW. 892 1650 Arthrogram Tray OII,892 1650 Radiology Dental Tray OIK. 892 1670 Device Spot Film IXL,892 1680 Radiographic Contrast Tray OIO. 892 1680 Radiology Diagnostic Kit OIP,892 1730 Discography Kit OIL.
892 1820 Chair Pneumocephalographic HBK,892 1850 Cassette Radiographic Film IXA. 892 1860 Changer Radiographic Film Cassette KPX, 892 1870 Programmer Changer Film Cassette Radiographic IZP. 892 1900 Controller Temperature Radiographic EGT,892 1900 Dryer Film Radiographic EGW. 892 1900 Processor Radiographic Film Automatic Dental EGY. 892 1900 Processor Radiographic Film Automatic IXW. 892 1900 Processor Cine Film IXX,892 2030 Digitizer Image Radiological LMA. mstockstill on DSK30JT082PROD with NOTICES,892 2030 Digitizer Images Ophthalmic NFH.
892 2040 Camera Multi Format Radiological LMC,892 2040 Device Hardcopy Images Ophthalmic NFI. 892 5730 Prostate Seeding Kit OIN, VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices 31981. In table 2 FDA is identifying a list of found in 862 9 to 892 9 as well as the partial exemption limitation specified in. class II devices that no longer require indicated partial exemption limitations table 2 and its corresponding general. premarket notification under section Devices listed in table 2 are now limitation found in the 9 section of. 510 k of the FD C Act subject to the exempt but only if they are in Parts 862 to 892 of Title 21 of the CFR. general limitations to the exemptions concurrent compliance with both the. TABLE 2 CLASS II DEVICES,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 862 3100 Enzyme Immunoassay Am PUX DKZ Exemption is limited to test systems intended for employ. phetamine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3100 Radioimmunoassay Amphet PUX DJP Exemption is limited to test systems intended for employ. amine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3100 Thin Layer Chromatography PUX DIT Exemption is limited to test systems intended for employ. Amphetamine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3100 Gas Chromatography Am PUX DOD Exemption is limited to test systems intended for employ. phetamine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3100 Liquid Chromatography Am PUX DNI Exemption is limited to test systems intended for employ. phetamine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3100 Free Radical Assay Amphet PUX DJL Exemption is limited to test systems intended for employ. amine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3150 Enzyme Immunoassay Bar PUY DIS Exemption is limited to test systems intended for employ. biturate ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. mstockstill on DSK30JT082PROD with NOTICES,Health Services Administration SAMHSA the Depart. ment of Transportation DOT and the U S military, VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. 31982 Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 862 3150 Radioimmunoassay Barbitu PUY DKN Exemption is limited to test systems intended for employ. rate ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3150 Thin Layer Chromatography PUY DKX Exemption is limited to test systems intended for employ. Barbiturate ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3150 Mercury Dithiazone Colorim PUY DJN Exemption is limited to test systems intended for employ. etry Barbiturate ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3150 Hemagglutination Inhibition PUY DLX Exemption is limited to test systems intended for employ. Barbiturate ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3150 Gas Liquid Chromatography PUY DMF Exemption is limited to test systems intended for employ. Barbiturate ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3150 High Pressure Liquid Chro PUY KZY Exemption is limited to test systems intended for employ. matography Barbiturate ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3170 Enzyme Immunoassay PUZ JXM Exemption is limited to test systems intended for employ. Benzodiazepine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3170 High Pressure Liquid Chro PUZ LAA Exemption is limited to test systems intended for employ. matography ment and insurance testing that include a statement in. Benzodiazepine their labeling that the device is intended solely for use in. employment and insurance testing and does not include. mstockstill on DSK30JT082PROD with NOTICES, test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices 31983. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 862 3170 Test Benzodiazepine Over PUZ NFV Exemption is limited to test systems intended for employ.
The Counter ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3170 Gas Chromatography PUZ KZZ Exemption is limited to test systems intended for employ. Benzodiazepine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3170 Thin Layer Chromatography PUZ LAB Exemption is limited to test systems intended for employ. Benzodiazepine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3250 Enzyme Immunoassay Co PVA DIO Exemption is limited to test systems intended for employ. caine and Cocaine Metabo ment and insurance testing that include a statement in. lites their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3250 Radioimmunoassay Cocaine PVA KLN Exemption is limited to test systems intended for employ. Metabolite ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3250 Enzyme Immunoassay Co PVA JXO Exemption is limited to test systems intended for employ. caine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3250 Hemagglutination Cocaine PVA DLN Exemption is limited to test systems intended for employ. Metabolites ment and insurance testing that include a statement in. Benzoylecgonine their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3250 Thin Layer Chromatography PVA DMN Exemption is limited to test systems intended for employ. Cocaine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. mstockstill on DSK30JT082PROD with NOTICES, test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. 31984 Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation.
product code code,non exempt, 862 3250 Free Radical Assay Cocaine PVA DIR Exemption is limited to test systems intended for employ. ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3250 Gas Chromatography Co PVA DIN Exemption is limited to test systems intended for employ. caine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3250 Thin Layer Chromatography PVA DOM Exemption is limited to test systems intended for employ. Benzoylecgonine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3250 High Pressure Liquid Chro PVA LAC Exemption is limited to test systems intended for employ. matography Cocaine and ment and insurance testing that include a statement in. Cocaine Metabolites their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3270 High Pressure Liquid Chro PVB LAE Exemption is limited to test systems intended for employ. matography Codeine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3270 Thin Layer Chromatography PVB DLD Exemption is limited to test systems intended for employ. Codeine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3270 Gas Chromatography Co PVB LAD Exemption is limited to test systems intended for employ. deine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3580 Radioimmunoassay LSD PVC DLB Exemption is limited to test systems intended for employ. 125 I ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. mstockstill on DSK30JT082PROD with NOTICES, test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices 31985. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 862 3580 Free Radical Assay LSD PVC DOL Exemption is limited to test systems intended for employ. ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3610 Gas Chromatography Meth PVD LAF Exemption is limited to test systems intended for employ. amphetamine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3610 Thin Layer Chromatography PVD DJC Exemption is limited to test systems intended for employ. Methamphetamine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3610 High Pressure Liquid Chro PVD LAG Exemption is limited to test systems intended for employ. matography Methamphet ment and insurance testing that include a statement in. amine their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3610 Test Methamphetamine PVD NGG Exemption is limited to test systems intended for employ. Over The Counter ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3620 Enzyme Immunoassay Meth PVE DJR Exemption is limited to test systems intended for employ. adone ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3620 Hemagglutination Inhibition PVE DIW Exemption is limited to test systems intended for employ. Methadone ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3620 Gas Chromatography Metha PVE DMB Exemption is limited to test systems intended for employ. done ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. mstockstill on DSK30JT082PROD with NOTICES, test systems intended for Federal drug testing programs.
e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. 31986 Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 862 3620 Thin Layer Chromatography PVE DKR Exemption is limited to test systems intended for employ. Methadone ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3620 Liquid Chromatography PVE DNT Exemption is limited to test systems intended for employ. Methadone ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3620 Free Radical Assay Metha PVE DPP Exemption is limited to test systems intended for employ. done ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3630 Radioimmunoassay Metha PVF KXS Exemption is limited to test systems intended for employ. qualone ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3640 Thin Layer Chromatography PVG DNK Exemption is limited to test systems intended for employ. Morphine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3640 Radioimmunoassay Mor PVG DOE Exemption is limited to test systems intended for employ. phine 123 I Goat Anti ment and insurance testing that include a statement in. body Ammonium Sulfate their labeling that the device is intended solely for use in. Sep employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3640 Fluorometry Morphine PVG DJJ Exemption is limited to test systems intended for employ. ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3640 Liquid Chromatography Mor PVG DPK Exemption is limited to test systems intended for employ. phine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. mstockstill on DSK30JT082PROD with NOTICES, test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices 31987. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 862 3640 Gas Chromatography Mor PVG DMY Exemption is limited to test systems intended for employ. phine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3640 Hemagglutination Inhibition PVG DLR Exemption is limited to test systems intended for employ. Morphine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3640 Free Radical Assay Mor PVG DOK Exemption is limited to test systems intended for employ. phine ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3640 Radioimmunoassay Mor PVG DIQ Exemption is limited to test systems intended for employ. phine 3 H Goat Antibody ment and insurance testing that include a statement in. Ammonium Sulfate Sep their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3640 Radioimmunoassay Mor PVG DNA Exemption is limited to test systems intended for employ. phine Barbiturate 125 I ment and insurance testing that include a statement in. Goat Antibody their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3650 Enzyme Immunoassay Opi PVH DJG Exemption is limited to test systems intended for employ. ates ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3650 Gas Chromatography Opi PVH DJF Exemption is limited to test systems intended for employ. ates ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3650 Hemagglutination Opiates PVH DLT Exemption is limited to test systems intended for employ. ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. mstockstill on DSK30JT082PROD with NOTICES, test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. 31988 Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 862 3650 Thin Layer Chromatography PVH LAI Exemption is limited to test systems intended for employ.
Opiates ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3650 Free Radical Assay Opiates PVH DKT Exemption is limited to test systems intended for employ. ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3650 High Pressure Liquid Chro PVH LAH Exemption is limited to test systems intended for employ. matography Opiates ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3700 Enzyme Immunoassay PVI JXN Exemption is limited to test systems intended for employ. Propoxyphene ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3700 Thin Layer Chromatography PVI DPN Exemption is limited to test systems intended for employ. Propoxyphene ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3700 Gas Chromatography PVI LAJ Exemption is limited to test systems intended for employ. Propoxyphene ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3700 High Pressure Liquid Chro PVI LAK Exemption is limited to test systems intended for employ. matography Propoxyphene ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3870 Enzyme Immunoassay PVJ LDJ Exemption is limited to test systems intended for employ. Cannabinoids ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. mstockstill on DSK30JT082PROD with NOTICES, test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices 31989. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation.
product code code,non exempt, 862 3870 Reagents Test PVJ DKE Exemption is limited to test systems intended for employ. Tetrahydrocannabinol ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3870 Radioimmunoassay PVJ LAT Exemption is limited to test systems intended for employ. Cannabinoid S ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3910 High Pressure Liquid Chro PVK LFI Exemption is limited to test systems intended for employ. matography Tricyclic ment and insurance testing that include a statement in. Antidepressant Drugs their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 862 3910 U V Spectrometry Tricyclic PVK LFH Exemption is limited to test systems intended for employ. Antidepressant Drugs ment and insurance testing that include a statement in. their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military.
862 3910 Thin Layer Chromatography PVK MLK Exemption is limited to test systems intended for employ. Tricyclic Antidepressant ment and insurance testing that include a statement in. Drugs their labeling that the device is intended solely for use in. employment and insurance testing and does not include. test systems intended for Federal drug testing programs. e g programs run by the Substance Abuse and Mental. Health Services Administration SAMHSA the Depart,ment of Transportation DOT and the U S military. 866 5750 System Test PUW DHB Exemption is limited to devices classified under 21 CFR. Radioallergosorbent 866 5750 that are intended to detect any of the allergens. RAST Immunological included in table 3 of this document. 868 2385 Analyzer Nitrogen Dioxide PUG MRQ Exemption is limited to standalone nitrogen dioxide ana. lyzers and not those that are components of nitric oxide. delivery systems intended to monitor nitrogen dioxide. levels during inhaled nitric oxide therapy, 870 1330 Wire Guide Catheter PTL DQX Exemption is limited to accessory torque devices that are. manually operated non patient contacting and intended. to manipulate non cerebral vascular guide wires, 870 1650 Syringe Balloon Inflation PTM MAV Exemption is limited to non patient contacting balloon infla. tion syringes intended only to inflate deflate balloon cath. eters and monitor pressure within the balloon, 870 2770 Analyzer Body Composition PUH MNW Exemption is limited to body composition analyzers which. are not intended to diagnose or treat any medical condi. 870 4400 Reservoir Blood PTN DTN Exemption is limited to cardiopulmonary bypass blood res. Cardiopulmonary Bypass ervoirs that do not contain defoamers or blood filters. 874 1090 Tester Auditory Impedance PTO ETY Exemption is limited to auditory impedance testers that are. in compliance with FDA recognized consensus standard. mstockstill on DSK30JT082PROD with NOTICES,ANSI S3 39.
874 1090 Tympanometer PTP NAS Exemption is limited to tympanometers that are in compli. ance with FDA recognized consensus standard ANSI, 876 1500 Endoscopic Magnetic Re PTQ FCC Exemption is limited to endoscopic magnetic retrievers in. triever tended for single use, 876 1500 Scissors For Cystoscope PTR KGD Exemption is limited to sterile scissors for cystoscope in. tended for single use, VerDate Sep 11 2014 18 01 Jul 10 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E FR FM 11JYN1 SGM 11JYN1. 31990 Federal Register Vol 82 No 131 Tuesday July 11 2017 Notices. TABLE 2 CLASS II DEVICES Continued,Exempt product, 21 CFR Section Device type Partial exemption limitation. product code code,non exempt, 876 1500 Endoscopic Grasping Cutting PTS OCZ Exemption is limited to disposable non powered.
Instrument Non Powered endoscopic grasping cutting instruments intended for sin. 876 5010 Catheter Biliary Surgical PTT GCA Exemption is limited to surgical biliary catheters that do not. include a balloon component, 876 5630 Catheter Peritoneal Long PTU FJS Exemption is limited to non patient contacting catheter fin. Term Indwelling ger grips intended for single use, 876 5630 Catheter Peritoneal Dialysis PTV FKO Exemption is limited to non patient contacting catheter fin. Single Use ger grips intended for single use, 876 5630 System Peritoneal Auto PTW FKX Exemption is limited to continuous ambulatory peritoneal di. matic Delivery alysis CAPD belts and catheter stands that do not in. clude weigh scales, 878 4370 Drape Surgical PUI KKX Exemption is limited to surgical drapes that do not include. an antimicrobial agent, 878 4495 Suture Nonabsorbable PTX GAQ Exemption is limited to steel monofilament sutures that are.
Steel Monofilament And uncoated and do not incorporate barbs. Multifilament Sterile, 882 1470 Computerized Cognitive As PTY PKQ Exemption is limited to computerized cognitive assessment. sessment Aid aids that are not intended for diagnostic assessment of. specific diseases or conditions and rely on inputs from. visual cues auditory cues and or functional use of the. 884 1630 Colposcope and PTZ HEX Exemption is limited to standard colposcopes and. Colpomicroscope colpomicroscopes that use only a white light source do. not use filters other than a green filter do not include. image analysis software and are not smartphone based. 884 4530 Tenaculum Uterine PUA HDC Exemption is limited to sterile uterine tenaculum devices. that do not use suction and are intended for single use. 884 6120 Accessory Assisted Repro PUB MQG Exemption is limited to simple embryo incubators with tem. duction perature gas and humidity control only syringe pumps. collection tube warmers dish plate microscope stage. warmers and controlled rate cryopreservation freezers. 884 6130 Microtools Assisted Repro PUC MQH Exemption is limited to assisted reproduction microtools pi. duction Pipettes pettes manufactured from glass, 884 6160 Labware Assisted Reproduc PUD MQK Exemption is limited to dishes and plates that are intended. tion for general assisted reproduction technology procedures. 886 1850 Biomicroscope Slit Lamp PUE HJO Exemption is limited to slit lamp AC powered biomicro. AC Powered scopes intended only for the visual examination of the. anterior segment of the eye are classified as Group 1. per FDA recognized consensus standard ANSI Z80 36, do not provide any quantitative output and are not in. tended for screening or automated diagnostic indications. 886 3320 Ocular Peg PUF MQU Exemption is limited to ocular pegs supplied sterile. In table 2 FDA included devices exemption criteria from premarket to the general limitations to the. classified under 866 5750 notification requirements The devices exemptions found in 866 9 While the. Radioallergosorbent RAST listed in table 3 are also classified under non exempt devices classified under.


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