Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- DHXSystem, Test, Carcinoembryonic Antigen2Product Code
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer2Product Code
- K220176Elecsys AFP2Cleared 510(K)
- K213626VITROS AFP2Cleared 510(K)
- K090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 64542Cleared 510(K)
- K081709OLYMPUS AFP - ALPHA-FETOPROTEIN2Cleared 510(K)
- K080017VIDAS AFP ASSAY2Cleared 510(K)
- K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC6002Cleared 510(K)
- K023894ST AIA-PACK AFP ENZYME IMMUNOASSAY2Cleared 510(K)
- K020807AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM2Cleared 510(K)
- K020806ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY2Cleared 510(K)
- K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-84002Cleared 510(K)
- P820060ABBOTT AXSYM AFP2PMA Approval
- P820060ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER2PMA Approval
- P820060ABBOTT ARCHITECHT AFP2PMA Approval
- P820060AFP CONTROL PACK2PMA Approval
- P820060ABBOTT AXSYM AFP2PMA Approval
- P820060ABBOTT IMX AFP ASSAY2PMA Approval
- K983031VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY2Cleared 510(K)
- K983263IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP22Cleared 510(K)
- K981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 332112Cleared 510(K)
- K981282ELECSYS AFP2Cleared 510(K)
- K973351ELECSYS AFP2Cleared 510(K)
- P820060ABBOTT AXSYM AFP2PMA Approval
- K972462AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM2Cleared 510(K)
- P820060ABBOTT AXSYM AFP2PMA Approval
- P820060ABBOTT AXSYM AFP (LIST 7A48)2PMA Approval
- P820060ABBOTT AXSYM AFP (LIST 7A48)2PMA Approval
- P820060ABBOTT AXSYM AFP (LIST 7A48)2PMA Approval
- P820060ABBOTT IMX AFP ADDITIONAL PURIFICATION STEP2PMA Approval
- P820060ABBOTT AFP-EIA LABELING CHANGE2PMA Approval
- P860044ENZYMUN-TEST{R} AFP2PMA Approval
- P860044ENZYMUN-TEST{R} AFP2PMA Approval
- P820060ABBOTT COMMANDER(R) PPC AFP-EIA2PMA Approval
- P860044ENZYMUN-TEST{R} AFP2PMA Approval
- P820060ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS2PMA Approval
- P840035TANDEM(R)-E AFP2PMA Approval
- P840035TANDEM(R)-E AFP2PMA Approval
- P840035TANDEM(R)-E AFP2PMA Approval
- P820060ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER2PMA Approval
- P840035TANDEM(R)-E AFP2PMA Approval
- P840035ENCORE AFP2PMA Approval
- P840035TANDEM(R)-E AFP2PMA Approval
- K851891TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS2Cleared 510(K)
- P820060ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER2PMA Approval
- P820060ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER2PMA Approval
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers2Product Code
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)2Product Code
- MMWSystem, Test, Tumor Marker, Monitoring, Bladder2Product Code
- MOISystem, Test, Immunological, Antigen, Tumor2Product Code
- MSWSystem, Test, Thyroglobulin2Product Code
- MUTKit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)2Product Code
- NCWSystem, Test, Her-2/Neu, Monitoring2Product Code
- NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer2Product Code
- NSFTest, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment2Product Code
- NTYSystem, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer2Product Code
- NVACancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma2Product Code
- OAUDes-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma2Product Code
- OIUTest, Epithelial Ovarian Tumor Associated Antigen (He4)2Product Code
- OVKCytokeratin Fragments 21-1 Eia Kit2Product Code
- ONXOvarian Adnexal Mass Assessment Score Test System2Product Code
- QTEThymidine Kinase Activity2Product Code
- QXSChromogranin A2Product Code
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
TANDEM(R)-E AFP
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- BECKMAN COULTER, INC.
- Trade Name
- TANDEM(R)-E AFP
- Generic Name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision Date
- 6/3/1988
- Days to Decision
- 28 days
- Decision Code
- APPR
- FDA Decision
- Approval