Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997

  • Print
  • Share
  • E-mail
-
See Related
Database Updated 08/12/2019

This page provides information on persons accredited (as of the above date of revision) to review selected premarket notifications [510(k)s] and the devices they may review.  Information on this list will be updated within 10 working days after the date reflected on the third party's accreditation letter.  Each classified device type on the list of devices eligible for Third Party Review has one or more product codes associated with it.  Devices eligible for review by Third Parties are limited to the product codes shown on the list of eligible devices.  Please refer to the List of Devices for Third Party Review Under the FDA Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person.
AABB
Accelerated Device Approval Services, LLC
Biomarkers and Diagnostics Consulting, LLC
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
New York State Department of Health
NIOM - NORDIC INSTITUTE OF DENTAL MATERIALS
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
TUV SUD AMERICA INC.
AABB
4550 Montgomery Road, North Tower Suite 700
Bethesda MD 20814    
Contact: Anne Chenoweth
Phone:1 301 2156492
Fax:
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
  864.5600 Automated hematocrit instrument. II
  864.5620 Automated hemoglobin system. 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
  864.8150 Calibrator for cell indices. II
  864.8165 Calibrator for hemoglobin or hematocrit measurement. II
  864.8175 Calibrator for platelet counting. II
  864.8185 Calibrator for red cell and white cell counting. II
  864.8625 Hematology quality control mixture. 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
top of page   
-
-