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U.S. Department of Health and Human Services

Reserved Medical Devices
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The following devices are devices that FDA believes meet the reserved criteria in section 206 of the Modernization Act and, therefore, would remain subject to premarket notification under new section 510(l) added to the act:

862.1065 Electrode, Ion-Specific Method, Ammonia (JIG)  
862.1065 Enzymatic Method, Ammonia (JIF)  
862.1065 Method, Ion-Exchange, Ammonia (JIE)  
862.1065 Photometric Method, Ammonia (JID)  
862.1113 Bilirubin (Total And Unbound) In The Neonate Test System (MQM)  
862.1310 Colorimetric Method, Galactose (JIC)  
862.1310 Enzymatic Methods, Galactose (JIA)  
862.1310 U.V. Method, Galactose (JIB)  
862.1495 Atomic Absorption, Magnesium (JGI)  
862.1495 Electrode, Ion Specific, Magnesium (CFA)  
862.1495 Photometric Method, Magnesium (JGJ)  
862.1495 Titrimetric, Magnesium (CFO)  
862.1680 Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ)  
862.1730 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine (CDR)  
862.1775 Uric Acid Test System For At Home Prescription Use (PTC)  
862.3110 Atomic Absorption, Antimony (DNE)  
862.3120 Atomic Absorption, Arsenic (DNZ)  
862.3600 Mercury, Atomic Absorption (DPH)  
862.3750 Eas Chromatography, Quinine (LAL)  
862.3750 High Pressure Liquid Chromatography, Quinine (LAM)  
862.3750 Thin Layer Chromatography, Quinine (DIK)  
862.3850 Test Reagents For Sulphanimide Derivatives (DKW)  
864.8950 Reagent, Russel Viper Venom (GIR)  
864.9050 Supplies, Blood-Bank (KSS)  
864.9125 System, Blood Collection, Vacuum-Assisted, Automated (MYX) 2  
866.2390 Culture Media, Anaerobic Transport (JSL)  
866.2390 Culture Media, Non-Propagating Transport (JSM)  
866.2390 Culture Media, Propagating Transport (JSN)  
866.2390 Transport Medium, Notified Per The Vtm Guidance (QMC)  
866.2560 System, Blood Culturing (MDB)  
866.2560 System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture (QBQ)  
866.2850 Reader, Zone, Automated (KZK)  
866.2900 Device, Specimen Collection (LIO)  
866.2900 Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) (OID)  
866.2900 System, Transport, Aerobic (JTW)  
866.2900 Transport Systems, Anaerobic (JTX)  
866.3110 Antiserum, Fluorescent, Campylobacter Fetus (GSP)  
866.3110 Campylobacter Spp. (LQP)  
866.3110 Dna-Reagents, Campylobacter Spp. (LQO)  
866.3110 Helicobacter Pylori (LYR)  
866.3110 Immunohistochemical Assay, Helicobacter Pylori (OWF)  
866.3110 Test, Urea (Breath Or Blood) (MSQ)  
866.3120 Antigen, Cf, Psittacosis (Chlamydia Group) (GPW)  
866.3120 Antisera, Fluorescent, Chlamydia Spp. (LKI)  
866.3120 Antisera, Immunoperoxidase, Chlamydia Spp. (LKH)  
866.3120 Antiserum, Cf, Psittacosis (Chlamydia Group) (GPT)  
866.3120 Antiserum, Fluorescent, Chlamydia Trachomatis (LJP)  
866.3120 C. Trachomatis (Chlamydia Group) (MGM)  
866.3120 Dna Probe, Nucleic Acid Amplification, Chlamydia (MKZ)  
866.3120 Dna-Reagents, Chlamydia (LSK)  
866.3120 Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) (LJC)  
866.3235 Antibody Igm, If, Epstein-Barr Virus (LJN)  
866.3235 Antigen, Cf (Including Cf Control), Epstein-Barr Virus (GNQ)  
866.3235 Antigen, Ebv, Capsid (MCD)  
866.3235 Antiserum, Cf, Epstein-Barr Virus (GNP)  
866.3235 Antiserum, Fluorescent, Epstein-Barr Virus (JRY)  
866.3235 Dna-Reagents, Epstein-Barr Virus (LSF)  
866.3235 Epstein-Barr Virus, Other (LSE)  
866.3235 Test, Antigen, Nuclear, Epstein-Barr Virus (LLM)  
866.3370 Antiserum, Fluorescent, Mycobacterium Tuberculosis (GRT)  
866.3370 Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis (NDZ)  
866.3370 Dna-Reagents, Mycobacterium Spp. (LQF)  
866.3370 System, Mycolic Acid Analysis, Mycobacterium Tuberculosis (NJO)  
866.3870 Antigen, Cf, T. Cruzi (GNF)  
866.3870 Antigen, Iha, T. Cruzi (GND)  
866.3870 Antigen, Latex Agglutination, T. Cruzi (GNE)  
866.3870 Enzyme Linked Immunosorbent Assay, T. Cruzi (MIU)  
866.3870 Immunofluorescent Assay, T. Cruzi (MIV)  
866.3870 Leishmania Spp. Antigen Detection Assay (PIT)  
866.3870 Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids (OUZ)  
866.3870 Reagent, Leishmanii Serological (LOO)  
872.4200 Controller, Foot, Handpiece And Cord (EBW)  
872.4200 Handpiece, Air-Powered, Dental (EFB)  
872.4200 Handpiece, Air-Powered, Root Canal Irrigation (NYL)  
872.4200 Handpiece, Belt And/Or Gear Driven, Dental (EFA)  
872.4200 Handpiece, Contra- And Right-Angle Attachment, Dental (EGS)  
872.4200 Handpiece, Direct Drive, Ac-Powered (EKX)  
872.4200 Handpiece, Water-Powered (EKY)  
872.6250 Chair, Dental, With Operative Unit (KLC) 18  
872.6640 General Purpose Dental Tray (OFX) 21  
872.6640 Unit, Operative Dental (EIA) 21  
872.6710 Sterilizer, Boiling Water (ECG)  
878.4460 Surgeon'S Gloves (KGO)  
880.5090 Bandage, Liquid (KMF) 8  
880.5680 Holder, Infant Position (FRP)  
880.5680 Infant Positioner, Rx, Use In Highly Monitored Setting (OUW)  
880.6250 Blood Borne Pathogen Response Kit (PWP)  
880.6250 Chemotherapy Administration Kit (PWS)  
880.6250 Chemotherapy Spill Clean-Up Kit (PWT)  
880.6250 Delivery Room Apparel Kit (PWV)  
880.6250 Fentanyl And Other Opioid Protection Glove (QDO)  
880.6250 Latex Patient Examination Glove (LYY)  
880.6250 Medical Glove, Specialty (LZC)  
880.6250 Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs (OPJ)  
880.6250 Patient Examination Glove (FMC)  
880.6250 Personal Protection Kit (PXC)  
880.6250 Polymer Patient Examination Glove (LZA)  
880.6250 Powder-Free Guayle Rubber Examination Glove (OIG)  
880.6250 Powder-Free Polychloroprene Patient Examination Glove (OPC)  
880.6250 Prep Kit (PXD)  
880.6250 Radiation Attenuating Medical Glove (OPH)  
880.6250 Vinyl Patient Examination Glove (LYZ)  
880.6375 Lubricant, Vaginal, Patient (MMS)  
880.6375 Oral Lubricant (ONK)  
882.1030 Ataxiagraph With Interpretive Software (PTB) 96  
882.1420 Analyzer, Spectrum, Electroencephalogram Signal (GWS)  
884.2980 System, Telethermographic (Adjunctive Use) (LHQ)  
884.2982 System, Thermographic, Liquid Crystal (LHM)  
884.2982 System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) (KYA)  
884.5435 Maternity Kit (PVT) 80  
886.4300 Folders And Injectors, Intraocular Lens (Iol) (MSS) 15  
886.4300 Graft Insertion Instrument For Endothelial Keratoplasty (OTZ) 15  
886.4300 Guide And Positioner, Ophthalmic Drug Delivery Device (QQQ) 15  
886.4300 Injector, Capsular Tension Ring (NCE) 15  
886.4370 Blade, Keratome, Reprocessed (NKY)  
886.4370 Keratome, Ac-Powered (HNO)  
886.4370 Keratome, Battery-Powered (HMY)  
886.4370 Keratome, Water Jet (MYD)  
890.3850 Stroller, Adaptive (LBE)  
890.3850 Wheelchair, Mechanical (IOR)  
890.5710 Infant Heel Warmer (Chemical Heat Pack) (MPO) 16  
892.1100 Camera, Scintillation (Gamma) (IYX)  
892.1110 Camera, Positron (IZC)  

Footnotes:

2

Exemption is limited to manual devices.

8

Exemption is limited to uses as a skin protectant.

15

Exemption does not apply if used as folders and injectors for soft or foldable IOL's.

16

Exemption does not apply when indicated for infants.

18

Only chairs without operative unit device are 510(k) exempt. Dental chair with operative unit, product code KLC, requires 510(k) clearance. Dental chair without operative unit, product code NRU, is exempt from 510(k).

21

Only the accessories tray to the unit is 510(k) exempt. Dental operative unit, product code EIA, requires 510(k) clearance. Oral cavity evacuator, product code EHZ , is exempt from 510(k). Saliva ejector mouthpiece, product code DYN , is exempt from 510(k). Suction operatory unit, product code EBR, is exempt from 510(k). Operative dental unit accessories, product code NRD, is exempt from 510(k).

80

510(k) exempt only when the device is made of common celluosic and synthetic material with an established safety profile.

96

Exemption is limited to ataxiagraphs that do not provide an interpretation or a clinical implication of the measurement
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