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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 Ammonia test system.  
862.1113 Bilirubin (total and unbound) in the neonate test system.  
862.1310 Galactose test system.  
862.1410 Iron (non-heme) test system.  
862.1415 Iron-binding capacity test system.  
862.1495 Magnesium test system.  
862.1580 Phosphorus (inorganic) test system.  
862.1660 Quality control material (assayed and unassayed). 1  
862.1680 Testosterone test system.  
862.1730 Free tyrosine test system.  
862.1775 Uric acid test system.  
862.3050 Breath-alcohol test system.  
862.3110 Antimony test system.  
862.3120 Arsenic test system.  
862.3220 Carbon monoxide test system.  
862.3240 Cholinesterase test system.  
862.3280 Clinical toxicology control material. 1  
862.3600 Mercury test system.  
862.3750 Quinine test system.  
862.3850 Sulfonamide test system.  
864.7040 Adenosine triphosphate release assay.  
864.8950 Russell viper venom reagent.  
864.9050 Blood bank supplies.  
864.9125 Vacuum-assisted blood collection system. 2  
866.2390 Transport culture medium.  
866.2560 Microbial growth monitor.  
866.2850 Automated zone reader.  
866.2900 Microbiological specimen collection and transport device.  
866.3110 Campylobacter fetus serological reagents.  
866.3120 Chlamydia serological reagents.  
866.3235 Epstein-Barr virus serological reagents.  
866.3370 Mycobacterium tuberculosis immunofluorescent reagents.  
866.3870 Trypanosoma spp. serological reagents.  
872.4200 Dental handpiece and accessories.  
872.6250 Dental chair and accessories. 18  
872.6640 Dental operative unit and accessories. 21  
872.6710 Boiling water sterilizer.  
878.4460 Surgeon's glove.  
880.5090 Liquid bandage. 8  
880.5680 Pediatric position holder.  
880.6250 Patient examination glove.  
880.6375 Patient lubricant.  
882.1420 Electroencephalogram (EEG) signal spectrum analyzer.  
884.2980 Telethermographic system.  
886.4300 Intraocular lens guide. 15  
886.4370 Keratome.  
890.3850 Mechanical wheelchair.  
890.5710 Hot or cold disposable pack. 16  
892.1100 Scintillation (gamma) camera.  
892.1110 Positron camera.  



Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.


Exemption is limited to manual devices.


Exemption is limited to uses as a skin protectant.


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


Exemption does not apply when indicated for infants.


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).


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).