Current List of FDA-Recognized 510(k) Third Party Review Organizations
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Current List of FDA-Recognized 510(k) Third Party Review Organizations

  • Print
  • Share
  • E-mail
-
see related
Database updated August 08, 2022

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.
AABB
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
AABB
 
4550 Montgomery Road, North Tower Suite 700
Bethesda MD 20814    
contact: Melanie Sloan
phone:1 301 2156540
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1475 Lipoprotein test system. I
  862.1675 Blood specimen collection device. II
  862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use. I
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.5220 Automated differential cell counter. II
  864.5260 Automated cell-locating device. II
  864.5300 Red cell indices device. II
  864.5400 Coagulation instrument. II
  864.5425 Multipurpose system for in vitro coagulation studies. II
  864.5700 Automated platelet aggregation system. II
  864.5950 Blood volume measuring device. II
  864.6550 Occult blood test. II
  864.6675 Platelet aggregometer. II
  864.7140 Activated whole blood clotting time tests. II
  864.7320 Fibrinogen/fibrin degradation products assay. II
  864.7340 Fibrinogen determination system. II
  864.7415 Abnormal hemoglobin assay. II
  864.7425 Carboxyhemoglobin assay. II
  864.7455 Fetal hemoglobin assay. II
  864.7500 Whole blood hemoglobin assays. II
  864.7525 Heparin assay. II
  864.7750 Prothrombin time test. II
  864.7825 Sickle cell test. II
  864.7875 Thrombin time test. II
  864.7925 Partial thromboplastin time tests. II
  864.9650 Quality control kit for blood banking reagents. II
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2800 Sterilization process indicator. II
  880.2910 Clinical electronic thermometer. II
  880.5440 Intravascular administration set. II
  880.5570 Hypodermic single lumen needle. II
  880.6250 Non-powdered patient examination glove. I
  880.6850 Sterilization wrap. II
  880.6870 Dry-heat sterilizer. II
  880.6880 Steam sterilizer. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 Antimicrobial susceptibility test disc. II
  866.1700 Culture medium for antimicrobial susceptibility tests. II
  866.2390 Transport culture medium. I
  866.2560 Microbial growth monitor. I
  866.2900 Microbiological specimen collection and transport device. I
  866.3175 Cytomegalovirus serological reagents. II
  866.3480 Respiratory syncytial virus serological reagents. I
  866.3820 Treponema pallidum nontreponemal test reagents. II
  866.3830 Treponema pallidum treponemal test reagents. II
top of page   
-
-