This page provides information on organizations recognized by FDA to review submissions under the 510(k) Third Party Review Program (formally, the Accredited Persons Program) and the devices they may review. Product codes eligible to review by a specific 3P510k Review Organization are listed under the following regulations. Devices eligible for review by 3P510k Review Organizations are limited to the product codes shown on the list of eligible devices. You can look up a given product code in the product code database, browse by 3P510k review organization in the list below or browse by device area to confirm eligibility of your device.
As of August 13, 2021, Accelerated Device Approval Services, LLC (ADAS) is no longer recognized to conduct 510(k) Third Party Reviews. For details, see the Accreditation Status section on the 510(k) Third Party Performance Metrics and Accreditation Status page. |
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New York State Department of Health
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| New York State Department of Health |
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Wadsworth Center, Empire State Plaza
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P.O. Box 509
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Albany
NY
12237
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| | contact: | Derek Symula |
| phone: | 518 4024372 |
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| Panel | Section Number | Regulation Name / Device Name | Class |
| Clinical Chemistry |
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862.1025 |
Adrenocorticotropic hormone (ACTH) test system. |
II |
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862.1035 |
Albumin test system. |
II |
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862.1045 |
Aldosterone test system. |
II |
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862.1050 |
Alkaline phosphatase or isoenzymes test system. |
II |
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862.1065 |
Ammonia test system. |
I |
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862.1070 |
Amylase test system. |
II |
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862.1085 |
Angiotensin I and renin test system. |
II |
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862.1110 |
Bilirubin (total or direct) test system. |
II |
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862.1113 |
Bilirubin (total and unbound) in the neonate test system. |
I |
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862.1118 |
Biotinidase test system. |
II |
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862.1120 |
Blood gases (PCO2, PO2) and blood pH test system. |
II |
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862.1140 |
Calcitonin test system. |
II |
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862.1145 |
Calcium test system. |
II |
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862.1155 |
Human chorionic gonadotropin (HCG) test system. |
II |
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862.1160 |
Bicarbonate/carbon dioxide test system. |
II |
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862.1170 |
Chloride test system. |
II |
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862.1177 |
Cholylglycine test system. |
II |
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862.1187 |
Conjugated sulfolithocholic acid (SLCG) test system. |
II |
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862.1205 |
Cortisol (hydrocortisone and hydroxycorticosterone) test system. |
II |
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862.1215 |
Creatine phosphokinase/creatine kinase or isoenzymes test system. |
II |
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862.1225 |
Creatinine test system. |
II |
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862.1230 |
Cyclic AMP test system. |
II |
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862.1295 |
Folic acid test system. |
II |
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862.1310 |
Galactose test system. |
I |
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862.1315 |
Galactose-1-phosphate uridyl transferase test system. |
II |
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862.1340 |
Urinary glucose (nonquantitative) test system. |
II |
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862.1345 |
Glucose test system. |
II |
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862.1377 |
Urinary homocystine (nonquantitative) test system. |
II |
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862.1455 |
Lecithin/sphingomyelin ratio in amniotic fluid test system. |
II |
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862.1495 |
Magnesium test system. |
I |
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862.1545 |
Parathyroid hormone test system. |
II |
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862.1555 |
Phenylalanine test system. |
II |
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862.1585 |
Human placental lactogen test system. |
II |
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862.1600 |
Potassium test system. |
II |
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862.1665 |
Sodium test system. |
II |
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862.1675 |
Blood specimen collection device. |
II |
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862.1680 |
Testosterone test system. |
I |
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862.1690 |
Thyroid stimulating hormone test system. |
II |
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862.1695 |
Free thyroxine test system. |
II |
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862.1730 |
Free tyrosine test system. |
I |
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862.1770 |
Urea nitrogen test system. |
II |
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862.1775 |
Uric acid test system. |
I |
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862.1810 |
Vitamin B[bdi1][bdi2] test system. |
II |
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862.1825 |
Vitamin D test system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Immunology |
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866.5080 |
Alpha-1-antichymotrypsin immunological test system. |
II |
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866.5090 |
Antimitochondrial antibody immunological test system. |
II |
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866.5100 |
Antinuclear antibody immunological test system. |
II |
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866.5120 |
Antismooth muscle antibody immunological test system. |
II |
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866.5130 |
Alpha-1-antitrypsin immunological test system. |
II |
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866.5150 |
Bence-Jones proteins immunological test system. |
II |
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866.5240 |
Complement components immunological test system. |
II |
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866.5250 |
Complement C[bdi2] inhibitor (inactivator) immunological test system. |
II |
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866.5260 |
Complement C3b inactivator immunological test system. |
II |
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866.5270 |
C-reactive protein immunological test system. |
II |
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866.5340 |
Ferritin immunological test system. |
II |
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866.5350 |
Fibrinopeptide A immunological test system. |
II |
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866.5510 |
Immunoglobulins A, G, M, D, and E immunological test system. |
II |
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866.5550 |
Immunoglobulin (light chain specific) immunological test system. |
II |
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866.5580 |
Alpha-1-lipoprotein immunological test system. |
II |
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866.5600 |
Low-density lipoprotein immunological test system. |
II |
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866.5640 |
Infectious mononucleosis immunological test system. |
II |
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866.5680 |
Myoglobin immunological test system. |
II |
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866.5775 |
Rheumatoid factor immunological test system. |
II |
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866.5820 |
Systemic lupus erythematosus immunological test system. |
II |
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866.5870 |
Thyroid autoantibody immunological test system. |
II |
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866.5880 |
Transferrin immunological test system. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Microbiology |
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866.1620 |
Antimicrobial susceptibility test disc. |
II |
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866.1640 |
Antimicrobial susceptibility test powder. |
II |
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866.1700 |
Culture medium for antimicrobial susceptibility tests. |
II |
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866.2390 |
Transport culture medium. |
I |
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866.2560 |
Microbial growth monitor. |
I |
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866.2850 |
Automated zone reader. |
I |
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866.2900 |
Microbiological specimen collection and transport device. |
I |
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866.3110 |
Campylobacter fetus serological reagents. |
I |
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866.3120 |
Chlamydia serological reagents. |
I |
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866.3175 |
Cytomegalovirus serological reagents. |
II |
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866.3235 |
Epstein-Barr virus serological reagents. |
I |
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866.3370 |
Mycobacterium tuberculosis immunofluorescent reagents. |
I |
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866.3390 |
Neisseria spp. direct serological test reagents. |
II |
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866.3510 |
Rubella virus serological reagents. |
II |
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866.3780 |
Toxoplasma gondii serological reagents. |
II |
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866.3820 |
Treponema pallidum nontreponemal test reagents. |
II |
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866.3830 |
Treponema pallidum treponemal test reagents. |
II |
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866.3870 |
Trypanosoma spp. serological reagents. |
I |
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866.3900 |
Varicella-zoster virus serological reagents. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Pathology |
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866.6080 |
Next generation sequencing based tumor profiling test. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Toxicology |
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862.3030 |
Acetaminophen test system. |
II |
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862.3035 |
Amikacin test system. |
II |
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862.3040 |
Alcohol test system. |
II |
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862.3100 |
Amphetamine test system. |
II |
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862.3110 |
Antimony test system. |
I |
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862.3120 |
Arsenic test system. |
I |
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862.3150 |
Barbiturate test system. |
II |
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862.3170 |
Benzodiazepine test system. |
II |
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862.3250 |
Cocaine and cocaine metabolite test system. |
II |
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862.3270 |
Codeine test system. |
II |
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862.3300 |
Digitoxin test system. |
II |
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862.3320 |
Digoxin test system. |
II |
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862.3350 |
Diphenylhydantoin test system. |
II |
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862.3380 |
Ethosuximide test system. |
II |
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862.3450 |
Gentamicin test system. |
II |
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862.3520 |
Kanamycin test system. |
II |
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862.3555 |
Lidocaine test system. |
II |
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862.3560 |
Lithium test system. |
II |
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862.3580 |
Lysergic acid diethylamide (LSD) test system. |
II |
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862.3600 |
Mercury test system. |
I |
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862.3610 |
Methamphetamine test system. |
II |
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862.3620 |
Methadone test system. |
II |
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862.3630 |
Methaqualone test system. |
II |
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862.3640 |
Morphine test system. |
II |
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862.3645 |
Neuroleptic drugs radioreceptor assay test system. |
II |
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862.3650 |
Opiate test system. |
II |
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862.3660 |
Phenobarbital test system. |
II |
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862.3670 |
Phenothiazine test system. |
II |
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862.3680 |
Primidone test system. |
II |
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862.3700 |
Propoxyphene test system. |
II |
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862.3750 |
Quinine test system. |
I |
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862.3830 |
Salicylate test system. |
II |
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862.3850 |
Sulfonamide test system. |
I |
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862.3870 |
Cannabinoid test system. |
II |
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862.3880 |
Theophylline test system. |
II |
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862.3900 |
Tobramycin test system. |
II |
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862.3910 |
Tricyclic antidepressant drugs test system. |
II |
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862.3950 |
Vancomycin test system. |
II |
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