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 21, 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
AABB
 
4550 Montgomery Road, North Tower Suite 700
Bethesda MD 20814    
contact: Anne Chenoweth
phone:1 301 2156492
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1675 Blood specimen collection device. II
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.5260 Automated cell-locating device. II
  864.5300 Red cell indices device. II
  864.7340 Fibrinogen determination system. II
  864.7415 Abnormal hemoglobin assay. II
  864.7455 Fetal hemoglobin assay. II
  864.7500 Whole blood hemoglobin assays. II
  864.7825 Sickle cell test. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.3175 Cytomegalovirus serological reagents. II
  866.3820 Treponema pallidum nontreponemal test reagents. II
  866.3830 Treponema pallidum treponemal test reagents. II
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