Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
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U.S. Department of Health and Human Services

Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
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Database Updated 12/09/2019

This page provides information on persons accredited (as of the above date of revision) to review selected premarket notifications [510(k)s] and the devices they may review.  Information on this list will be updated within 10 working days after the date reflected on the third party's accreditation letter.  Each classified device type on the list of devices eligible for Third Party Review has one or more product codes associated with it.  Devices eligible for review by Third Parties are limited to the product codes shown on the list of eligible devices.  Please refer to the List of Devices for Third Party Review Under the FDA Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person.
AABB
Accelerated Device Approval Services, LLC
Biomarkers and Diagnostics Consulting, LLC
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
New York State Department of Health
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
TUV SUD AMERICA INC.
New York State Department of Health
Wadsworth Center, Empire State Plaza
P.O. Box 509
Albany NY 12201    
Contact: Erasmus Schneider
Phone: 518 4734856
Fax: 518 4743439
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1020 Acid phosphatase (total or prostatic) test system. II
  862.1025 Adrenocorticotropic hormone (ACTH) test system. II
  862.1035 Albumin test system. II
  862.1045 Aldosterone test system. II
  862.1050 Alkaline phosphatase or isoenzymes test system. II
  862.1065 Ammonia test system. I
  862.1070 Amylase test system. II
  862.1085 Angiotensin I and renin test system. II
  862.1090 Angiotensin converting enzyme (A.C.E.) test system. II
  862.1100 Aspartate amino transferase (AST/SGOT) test system. II
  862.1110 Bilirubin (total or direct) test system. II
  862.1113 Bilirubin (total and unbound) in the neonate test system. I
  862.1118 Biotinidase test system. II
  862.1120 Blood gases (PCO2, PO2) and blood pH test system. II
  862.1140 Calcitonin test system. II
  862.1145 Calcium test system. II
  862.1150 Calibrator. II
  862.1155 Human chorionic gonadotropin (HCG) test system. II
  862.1160 Bicarbonate/carbon dioxide test system. II
  862.1170 Chloride test system. II
  862.1177 Cholylglycine test system. II
  862.1187 Conjugated sulfolithocholic acid (SLCG) test system. II
  862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system. II
  862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system. II
  862.1225 Creatinine test system. II
  862.1230 Cyclic AMP test system. II
  862.1295 Folic acid test system. II
  862.1310 Galactose test system. I
  862.1315 Galactose-1-phosphate uridyl transferase test system. II
  862.1340 Urinary glucose (nonquantitative) test system. II
  862.1345 Glucose test system. II
  862.1377 Urinary homocystine (nonquantitative) test system. II
  862.1410 Iron (non-heme) test system. I
  862.1415 Iron-binding capacity test system. I
  862.1445 Lactate dehydrogenase isoenzymes test system. II
  862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system. II
  862.1495 Magnesium test system. I
  862.1509 Methylmalonic acid (nonquantitative) test system. II
  862.1545 Parathyroid hormone test system. II
  862.1555 Phenylalanine test system. II
  862.1580 Phosphorus (inorganic) test system. I
  862.1585 Human placental lactogen test system. II
  862.1600 Potassium test system. II
  862.1660 Quality control material (assayed and unassayed). I
  862.1665 Sodium test system. II
  862.1675 Blood specimen collection device. II
  862.1680 Testosterone test system. I
  862.1685 Thyroxine-binding globulin test system. II
  862.1690 Thyroid stimulating hormone test system. II
  862.1695 Free thyroxine test system. II
  862.1700 Total thyroxine test system. II
  862.1730 Free tyrosine test system. I
  862.1770 Urea nitrogen test system. II
  862.1775 Uric acid test system. I
  862.1810 Vitamin B[bdi1][bdi2] test system. II
  862.1825 Vitamin D test system. II
  862.2250 Gas liquid chromatography system for clinical use. I
PanelSection Number       Regulation Name / Device Name      Class
Immunology
  866.5080 Alpha-1-antichymotrypsin immunological test system. II
  866.5090 Antimitochondrial antibody immunological test system. II
  866.5100 Antinuclear antibody immunological test system. II
  866.5120 Antismooth muscle antibody immunological test system. II
  866.5130 Alpha-1-antitrypsin immunological test system. II
  866.5150 Bence-Jones proteins immunological test system. II
  866.5240 Complement components immunological test system. II
  866.5250 Complement C[bdi2] inhibitor (inactivator) immunological test system. II
  866.5260 Complement C3b inactivator immunological test system. II
  866.5270 C-reactive protein immunological test system. II
  866.5340 Ferritin immunological test system. II
  866.5350 Fibrinopeptide A immunological test system. II
  866.5510 Immunoglobulins A, G, M, D, and E immunological test system. II
  866.5550 Immunoglobulin (light chain specific) immunological test system. II
  866.5580 Alpha-1-lipoprotein immunological test system. II
  866.5600 Low-density lipoprotein immunological test system. II
  866.5620 Alpha-2-macroglobulin immunological test system. II
  866.5630 Beta-2-microglobulin immunological test system. II
  866.5640 Infectious mononucleosis immunological test system. II
  866.5680 Myoglobin immunological test system. II
  866.5775 Rheumatoid factor immunological test system. II
  866.5820 Systemic lupus erythematosus immunological test system. II
  866.5870 Thyroid autoantibody immunological test system. II
  866.5880 Transferrin immunological test system. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 Antimicrobial susceptibility test disc. II
  866.1640 Antimicrobial susceptibility test powder. II
  866.1700 Culture medium for antimicrobial susceptibility tests. II
  866.2390 Transport culture medium. I
  866.2560 Microbial growth monitor. I
  866.2850 Automated zone reader. I
  866.2900 Microbiological specimen collection and transport device. I
  866.3110 Campylobacter fetus serological reagents. I
  866.3120 Chlamydia serological reagents. I
  866.3175 Cytomegalovirus serological reagents. II
  866.3235 Epstein-Barr virus serological reagents. I
  866.3370 Mycobacterium tuberculosis immunofluorescent reagents. I
  866.3390 Neisseria spp. direct serological test reagents. II
  866.3510 Rubella virus serological reagents. II
  866.3780 Toxoplasma gondii serological reagents. II
  866.3820 Treponema pallidum nontreponemal test reagents. II
  866.3830 Treponema pallidum treponemal test reagents. II
  866.3870 Trypanosoma spp. serological reagents. I
  866.3900 Varicella-zoster virus serological reagents. II
PanelSection Number       Regulation Name / Device Name      Class
Pathology
  866.6080 Next generation sequencing based tumor profiling test. II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3030 Acetaminophen test system. II
  862.3035 Amikacin test system. II
  862.3040 Alcohol test system. II
  862.3050 Breath-alcohol test system. I
  862.3100 Amphetamine test system. II
  862.3110 Antimony test system. I
  862.3120 Arsenic test system. I
  862.3150 Barbiturate test system. II
  862.3170 Benzodiazepine test system. II
  862.3200 Clinical toxicology calibrator. II
  862.3220 Carbon monoxide test system. I
  862.3240 Cholinesterase test system. I
  862.3250 Cocaine and cocaine metabolite test system. II
  862.3270 Codeine test system. II
  862.3280 Clinical toxicology control material. I
  862.3300 Digitoxin test system. II
  862.3320 Digoxin test system. II
  862.3350 Diphenylhydantoin test system. II
  862.3380 Ethosuximide test system. II
  862.3450 Gentamicin test system. II
  862.3520 Kanamycin test system. II
  862.3550 Lead test system. II
  862.3555 Lidocaine test system. II
  862.3560 Lithium test system. II
  862.3580 Lysergic acid diethylamide (LSD) test system. II
  862.3600 Mercury test system. I
  862.3610 Methamphetamine test system. II
  862.3620 Methadone test system. II
  862.3630 Methaqualone test system. II
  862.3640 Morphine test system. II
  862.3645 Neuroleptic drugs radioreceptor assay test system. II
  862.3650 Opiate test system. II
  862.3660 Phenobarbital test system. II
  862.3670 Phenothiazine test system. II
  862.3680 Primidone test system. II
  862.3700 Propoxyphene test system. II
  862.3750 Quinine test system. I
  862.3830 Salicylate test system. II
  862.3850 Sulfonamide test system. I
  862.3870 Cannabinoid test system. II
  862.3880 Theophylline test system. II
  862.3900 Tobramycin test system. II
  862.3910 Tricyclic antidepressant drugs test system. II
  862.3950 Vancomycin test system. II
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