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 September 28, 2020

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. 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.
AABB
Accelerated Device Approval Services, LLC
Biomarkers and Diagnostics Consulting, LLC
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
COLA, Inc.
New York State Department of Health
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
COLA, Inc.
 
9881 Broken Land Parkway
Columbia MD 21046    
ThirdParty@cola.org
contact: Brian Reuwer
phone:1 800 9819883
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1155 Human chorionic gonadotropin (HCG) test system. II
  862.1345 Glucose test system. II
  862.1825 Vitamin D test system. 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
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