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 January 25, 2021

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.
AABB
Accelerated Device Approval Services
BeanStock Ventures
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
COLA, Inc.
Global Quality and Regulatory Services
New York State Department of Health
REGULATORY TECHNOLOGY SERVICES, LLC
SGS North America
THIRD PARTY REVIEW GROUP, LLC
COLA, Inc.
 
10 Scenic Way
Monroe NJ 08831    
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
  862.1345 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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