Current List of FDA-Recognized 510(k) Third Party Review Organizations
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U.S. Department of Health and Human Services

Current List of FDA-Recognized 510(k) Third Party Review Organizations
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Database updated October 12, 2026

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.
Center For Measurement Standards of Industrial
COLA, Inc.
Global Quality and Regulatory Services
Regulatory Technology Services, LLC
Scarlet NB B.V
SMO India
Third Party Review Group, LLC
COLA, Inc.
 
9881 Broken Land Pkwy.
Suite 200
Columbia MD 21046
ThirdParty@cola.org
contact: Kathy Nucifora
phone:1 800 9819883
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1155 Human chorionic gonadotropin (HCG) test system. II
  862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system. II
  862.1225 Creatinine test system. II
  862.1295 Folic acid test system. II
  862.1340 Urinary glucose (nonquantitative) test system. II
  862.1345 Glucose test system. II
  862.1545 Parathyroid hormone test system. II
  862.1680 Testosterone test system. I
  862.1690 Thyroid stimulating hormone test system. II
  862.1695 Free thyroxine test system. II
  862.1810 Vitamin B[bdi1][bdi2] test system. II
  862.1825 Vitamin D test system. II
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.6550 Occult blood test. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 Antimicrobial susceptibility test disc. II
  866.2390 Transport culture medium. I
  866.2560 Microbial growth monitor. I
  866.2900 Microbiological specimen collection and transport device. I
  866.3390 Neisseria spp. direct serological test reagents. II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3100 Amphetamine test system. II
  862.3150 Barbiturate test system. II
  862.3170 Benzodiazepine test system. II
  862.3250 Cocaine and cocaine metabolite test system. II
  862.3610 Methamphetamine test system. II
  862.3620 Methadone test system. II
  862.3640 Morphine test system. II
  862.3650 Opiate test system. II
  862.3700 Propoxyphene test system. II
  862.3870 Cannabinoid test system. II
  862.3910 Tricyclic antidepressant drugs test system. II
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