Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
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U.S. Department of Health and Human Services

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

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Database Updated 08/19/2019

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 To-date, FDA has not withdrawn accreditation from any Accredited Person.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.
Biomarkers and Diagnostics Consulting, LLC
10 Scenic Way
Monroe NJ 08831    
Contact: Abdel-Baset Halim, Dr.
Phone: 828 6066304
Fax: 732 6051439
Internet:
http://www.biomarkerconsult.com
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1025 Adrenocorticotropic hormone (ACTH) test system. II
  862.1035 Albumin test system. II
  862.1045 Aldosterone test system. II
  862.1065 Ammonia test system. I
  862.1085 Angiotensin I and renin test system. II
  862.1113 Bilirubin (total and unbound) in the neonate test system. I
  862.1118 Biotinidase test system. II
  862.1145 Calcium test system. II
  862.1155 Human chorionic gonadotropin (HCG) test system. II
  862.1177 Cholylglycine test system. II
  862.1187 Conjugated sulfolithocholic acid (SLCG) test system. II
  862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system. II
  862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system. II
  862.1225 Creatinine test system. II
  862.1295 Folic acid test system. II
  862.1315 Galactose-1-phosphate uridyl transferase test system. II
  862.1345 Glucose test system. II
  862.1377 Urinary homocystine (nonquantitative) test system. II
  862.1415 Iron-binding capacity test system. I
  862.1445 Lactate dehydrogenase isoenzymes test system. II
  862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system. II
  862.1495 Magnesium test system. I
  862.1509 Methylmalonic acid (nonquantitative) test system. II
  862.1545 Parathyroid hormone test system. II
  862.1555 Phenylalanine test system. II
  862.1585 Human placental lactogen test system. II
  862.1665 Sodium test system. II
  862.1675 Blood specimen collection device. II
  862.1685 Thyroxine-binding globulin test system. II
  862.1695 Free thyroxine test system. II
  862.1775 Uric acid test system. I
  862.1825 Vitamin D test system. II
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.5425 Multipurpose system for in vitro coagulation studies. II
  864.7275 Euglobulin lysis time tests. II
  864.7375 Glutathione reductase assay. II
  864.7415 Abnormal hemoglobin assay. II
  864.7425 Carboxyhemoglobin assay. II
  864.7455 Fetal hemoglobin assay. II
  864.7825 Sickle cell test. 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
Immunology
  866.5775 Rheumatoid factor immunological test system. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.3175 Cytomegalovirus serological reagents. II
  866.3235 Epstein-Barr virus serological reagents. I
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3035 Amikacin test system. II
  862.3555 Lidocaine test system. II
  862.3645 Neuroleptic drugs radioreceptor assay test system. II
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