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. |
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| SGS North America |
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201 ROUTE 17
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RUTHERFORD
NJ
07070
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http://www.sgs.com
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| | contact: | Josephine Obidigbo |
| phone: | 201 2965353 |
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| Panel | Section 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 |
| Panel | Section 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 |
| Panel | Section 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 |
| Panel | Section 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 |
| Panel | Section 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 |
| Panel | Section 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 |
| Panel | Section 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 |
| Panel | Section 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 |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Pathology |
| |
866.6080 |
Next generation sequencing based tumor profiling test. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Physical Medicine |
| |
890.3850 |
Mechanical wheelchair. |
I |
| Panel | Section 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 |
| Panel | Section 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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