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 June 20, 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
SGS North America
 
201 ROUTE 17
RUTHERFORD NJ 07070    
http://www.sgs.com
contact: Josephine Obidigbo
phone: 201 2965353
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
  862.1050 Alkaline phosphatase or isoenzymes test system. II
  862.1065 Ammonia test system. I
  862.1070 Amylase test system. II
  862.1085 Angiotensin I and renin test system. II
  862.1110 Bilirubin (total or direct) test system. II
  862.1113 Bilirubin (total and unbound) in the neonate test system. I
  862.1118 Biotinidase test system. II
  862.1120 Blood gases (PCO2, PO2) and blood pH test system. II
  862.1140 Calcitonin test system. II
  862.1145 Calcium test system. II
  862.1155 Human chorionic gonadotropin (HCG) test system. II
  862.1160 Bicarbonate/carbon dioxide test system. II
  862.1170 Chloride test system. II
  862.1175 Cholesterol (total) test system. I
  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
  862.1230 Cyclic AMP test system. II
  862.1235 Cyclosporine test system. II
  862.1295 Folic acid test system. II
  862.1310 Galactose test system. I
  862.1315 Galactose-1-phosphate uridyl transferase test system. II
  862.1340 Urinary glucose (nonquantitative) test system. II
  862.1345 Glucose test system. II
  862.1377 Urinary homocystine (nonquantitative) test system. II
  862.1450 Lactic acid test system. I
  862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system. II
  862.1475 Lipoprotein test system. I
  862.1495 Magnesium test system. I
  862.1510 Nitrite (nonquantitative) test system. I
  862.1540 Osmolality test system. I
  862.1545 Parathyroid hormone test system. II
  862.1550 Urinary pH (nonquantitative) test system. I
  862.1585 Human placental lactogen test system. II
  862.1600 Potassium test system. II
  862.1665 Sodium test system. II
  862.1675 Blood specimen collection device. II
  862.1678 Tacrolimus test system. II
  862.1680 Testosterone test system. I
  862.1690 Thyroid stimulating hormone test system. II
  862.1695 Free thyroxine test system. II
  862.1705 Triglyceride test system. I
  862.1730 Free tyrosine test system. I
  862.1770 Urea nitrogen test system. II
  862.1775 Uric acid test system. I
  862.1810 Vitamin B[bdi1][bdi2] test system. II
  862.1825 Vitamin D test system. II
  862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use. I
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1200 Diagnostic intravascular catheter. II
  870.1210 Continuous flush catheter. II
  870.1240 Flow-directed catheter. II
  870.1250 Percutaneous catheter. II
  870.1290 Steerable catheter control system. II
  870.1300 Catheter cannula. II
  870.1310 Vessel dilator for percutaneous catheterization. II
  870.1330 Catheter guide wire. II
  870.1340 Catheter introducer. II
  870.1370 Catheter tip occluder. II
  870.1380 Catheter stylet. II
  870.1390 Trocar. II
  870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing. II
  870.4450 Vascular clamp. II
  870.4475 Surgical vessel dilator. II
  870.4875 Intraluminal artery stripper. II
  870.5150 Embolectomy catheter. II
  870.5175 Septostomy catheter. II
  870.5900 Thermal regulating system. II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.3070 Dental amalgam, mercury, and amalgam alloy. II
  872.3200 Resin tooth bonding agent. II
  872.3240 Dental bur. I
  872.3250 Calcium hydroxide cavity liner. II
  872.3260 Cavity varnish. II
  872.3275 Dental cement. II
  872.3310 Coating material for resin fillings. II
  872.3660 Impression material. II
  872.3690 Tooth shade resin material. II
  872.3750 Bracket adhesive resin and tooth conditioner. II
  872.3760 Denture relining, repairing, or rebasing resin. II
  872.3765 Pit and fissure sealant and conditioner. II
  872.3770 Temporary crown and bridge resin. II
  872.3820 Root canal filling resin. II
  872.3920 Porcelain tooth. II
  872.5470 Orthodontic plastic bracket. II
  872.6660 Porcelain powder for clinical use. II
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.1860 Immunohistochemistry reagents and kits. II
  864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization. II
  864.5200 Automated cell counter. II
  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
  864.5680 Automated heparin analyzer. 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
  864.7010 Flow Cytometric Test System For Hematopoietic Neoplasms II
  864.7060 Antithrombin III assay. II
  864.7100 Red blood cell enzyme assay. II
  864.7140 Activated whole blood clotting time tests. II
  864.7280 Factor V Leiden DNA mutation detection systems. II
  864.7290 Factor deficiency test. II
  864.7320 Fibrinogen/fibrin degradation products assay. II
  864.7340 Fibrinogen determination system. II
  864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay. II
  864.7400 Hemoglobin A[bdi2] assay. II
  864.7415 Abnormal hemoglobin assay. II
  864.7425 Carboxyhemoglobin assay. II
  864.7440 Electrophoretic hemoglobin analysis system. II
  864.7455 Fetal hemoglobin assay. II
  864.7490 Sulfhemoglobin assay. II
  864.7500 Whole blood hemoglobin assays. II
  864.7525 Heparin assay. II
  864.7695 Platelet factor 4 radioimmunoassay. 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
  864.8100 Bothrops atrox reagent. II
  864.8950 Russell viper venom reagent. I
  864.9650 Quality control kit for blood banking reagents. II
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.5090 Liquid bandage. I
  880.5200 Intravascular catheter. II
  880.5240 Medical adhesive tape and adhesive bandage. I
  880.5440 Intravascular administration set. II
  880.5570 Hypodermic single lumen needle. II
  880.5860 Piston syringe. II
  880.6250 Non-powdered patient examination glove. I
PanelSection Number       Regulation Name / Device Name      Class
Immunology
  866.4750 Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use II
  866.5080 Alpha-1-antichymotrypsin immunological test system. II
  866.5090 Antimitochondrial antibody immunological test system. II
  866.5100 Antinuclear antibody immunological test system. II
  866.5110 Antiparietal antibody immunological test system. II
  866.5120 Antismooth muscle antibody immunological test system. II
  866.5130 Alpha-1-antitrypsin immunological test system. II
  866.5150 Bence-Jones proteins immunological test system. II
  866.5180 Fecal calprotectin immunological test system. II
  866.5240 Complement components immunological test system. II
  866.5250 Complement C[bdi2] inhibitor (inactivator) immunological test system. II
  866.5260 Complement C3b inactivator immunological test system. II
  866.5270 C-reactive protein immunological test system. II
  866.5340 Ferritin immunological test system. II
  866.5350 Fibrinopeptide A immunological test system. II
  866.5500 Hypersensitivity pneumonitis immunological test system. II
  866.5510 Immunoglobulins A, G, M, D, and E immunological test system. II
  866.5550 Immunoglobulin (light chain specific) immunological test system. II
  866.5580 Alpha-1-lipoprotein immunological test system. II
  866.5600 Low-density lipoprotein immunological test system. II
  866.5640 Infectious mononucleosis immunological test system. II
  866.5660 Multiple autoantibodies immunological test system. II
  866.5665 Aquaporin-4 Autoantibody II
  866.5670 Zinc Transporter 8 Auto-Antibody II
  866.5680 Myoglobin immunological test system. II
  866.5750 Radioallergosorbent (RAST) immunological test system. II
  866.5760 Tryptase test system. II
  866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems. II
  866.5820 Systemic lupus erythematosus immunological test system. II
  866.5830 Brain Trauma Assessment Test II
  866.5870 Thyroid autoantibody immunological test system. II
  866.5880 Transferrin immunological test system. II
  866.5930 Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System II
  866.6010 Tumor-associated antigen immunological test system. II
  866.6030 AFP-L3% immunological test system. II
  866.6040 Gene expression profiling test system for breast cancer prognosis. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.1620 Antimicrobial susceptibility test disc. II
  866.1640 Antimicrobial susceptibility test powder. II
  866.1700 Culture medium for antimicrobial susceptibility tests. II
  866.2050 Staphylococcal typing bacteriophage. I
  866.2190 Microbial Colony Image Assessment System II
  866.2360 Selective culture medium. I
  866.2390 Transport culture medium. I
  866.2410 Culture medium for pathogenic Neisseria spp. II
  866.2560 Microbial growth monitor. I
  866.2900 Microbiological specimen collection and transport device. I
  866.3040 Aspergillus spp. serological reagents. I
  866.3110 Campylobacter fetus serological reagents. I
  866.3120 Chlamydia serological reagents. I
  866.3175 Cytomegalovirus serological reagents. II
  866.3235 Epstein-Barr virus serological reagents. I
  866.3330 Influenza virus serological reagents. I
  866.3370 Mycobacterium tuberculosis immunofluorescent reagents. I
  866.3390 Neisseria spp. direct serological test reagents. II
  866.3400 Parainfluenza virus serological reagents. I
  866.3480 Respiratory syncytial virus serological reagents. I
  866.3510 Rubella virus serological reagents. II
  866.3780 Toxoplasma gondii serological reagents. II
  866.3820 Treponema pallidum nontreponemal test reagents. II
  866.3830 Treponema pallidum treponemal test reagents. II
  866.3870 Trypanosoma spp. serological reagents. I
  866.3900 Varicella-zoster virus serological reagents. II
  866.3920 Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays II
PanelSection Number       Regulation Name / Device Name      Class
Ophthalmic
  886.4300 Intraocular lens guide. I
  886.5916 Rigid gas permeable contact lens. II
  886.5918 Rigid gas permeable contact lens care products. II
  886.5925 Soft (hydrophilic) contact lens. II
PanelSection Number       Regulation Name / Device Name      Class
Pathology
  866.6080 Next generation sequencing based tumor profiling test. II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.3850 Mechanical wheelchair. I
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4040 Surgical apparel. II
  878.4370 Surgical drape and drape accessories. II
  878.4460 Non-powdered surgeon's glove. I
  878.4800 Manual surgical instrument for general use. I
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3030 Acetaminophen test system. II
  862.3035 Amikacin test system. II
  862.3040 Alcohol test system. II
  862.3100 Amphetamine test system. II
  862.3110 Antimony test system. I
  862.3120 Arsenic test system. I
  862.3150 Barbiturate test system. II
  862.3170 Benzodiazepine test system. II
  862.3250 Cocaine and cocaine metabolite test system. II
  862.3270 Codeine test system. II
  862.3300 Digitoxin test system. II
  862.3320 Digoxin test system. II
  862.3350 Diphenylhydantoin test system. II
  862.3360 Drug metabolizing enzyme genotyping system. II
  862.3380 Ethosuximide test system. II
  862.3450 Gentamicin test system. II
  862.3520 Kanamycin test system. II
  862.3555 Lidocaine test system. II
  862.3560 Lithium test system. II
  862.3580 Lysergic acid diethylamide (LSD) test system. II
  862.3590 Meprobamate Test System II
  862.3600 Mercury test system. I
  862.3610 Methamphetamine test system. II
  862.3620 Methadone test system. II
  862.3630 Methaqualone test system. II
  862.3640 Morphine test system. II
  862.3645 Neuroleptic drugs radioreceptor assay test system. II
  862.3650 Opiate test system. II
  862.3660 Phenobarbital test system. II
  862.3670 Phenothiazine test system. II
  862.3680 Primidone test system. II
  862.3700 Propoxyphene test system. II
  862.3750 Quinine test system. I
  862.3830 Salicylate test system. II
  862.3840 Sirolimus test system. II
  862.3850 Sulfonamide test system. I
  862.3870 Cannabinoid test system. II
  862.3880 Theophylline test system. II
  862.3900 Tobramycin test system. II
  862.3910 Tricyclic antidepressant drugs test system. II
  862.3950 Vancomycin test system. II
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