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
- K223921Access CEA2Cleared 510(K)
- K231517VITROS Immunodiagnostic Products CEA Reagent Pack2Cleared 510(K)
- K200215ADVIA Centaur CEA Assay2Cleared 510(K)
- K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN2Cleared 510(K)
- K080194VIDAS CEA (S) ASSAY2Cleared 510(K)
- K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)2Cleared 510(K)
- K041322VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS2Cleared 510(K)
- K031270ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS2Cleared 510(K)
- K023893ST AIA-PACK CEA ENZYME IMMUNOASSAY2Cleared 510(K)
- K013568CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM2Cleared 510(K)
- K991707MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 332062Cleared 510(K)
- K990943VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK2Cleared 510(K)
- K990774ABBOTT ARCHITECT CEA2Cleared 510(K)
- K981985ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 332092Cleared 510(K)
- K981478ACS:CENTAUR CEA2Cleared 510(K)
- K980887ELECSYS CEA ON THE ELECSYS 10102Cleared 510(K)
- K980855IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT2Cleared 510(K)
- K970877IMMULITE CEA2Cleared 510(K)
- P840019TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P920021OPUS(R) CEA TEST SYSTEM2PMA Approval
- P830066ABBOTT CEA-RIA MONOCLONAL2PMA Approval
- P830066ABBOTT AXSYM CEA (LIST 7A47)2PMA Approval
- P840019STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY2PMA Approval
- P840019TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P860058ENZYMUN TEST{R} CEA2PMA Approval
- K924857AIA-PACK CEA CALIBRATION VERIFICATION TEST SET2Cleared 510(K)
- P830066ABBOTT IMX-CEA (LIST 3A33)2PMA Approval
- P840019TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY2PMA Approval
- P830066ABBOTT CEA-EIA2PMA Approval
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P830066ABBOTT CEA-EIA2PMA Approval
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P840027CEA-ROCHE(R) EIA2PMA Approval
- P840027CEA-ROCHE(R) EIA2PMA Approval
- P840027CEA-ROCHE(R) EIA2PMA Approval
- P840027CEA-ROCHE(R) EIA2PMA Approval
- P830066ABBOTT CEA-EIA2PMA Approval
- P830066ABBOTT CEA-EIA ONE-STEP2PMA Approval
- K864877TRI-LEVEL LIGAND CONTROL2Cleared 510(K)
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P840027CEA-ROCHE(R) EIA2PMA Approval
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P840027CEA-ROCHE(R) EIA2PMA Approval
- P830066ABBOTT CEA-EIA KIT2PMA Approval
- P830066ABBOTT CEA-EIA KIT2PMA Approval
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P840027CEA-ROCHE(R) EIA2PMA Approval
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY2PMA Approval
- P830066CEA-RIA MONOCLONAL2PMA Approval
- K833318NORMAL GOAT SERUM2Cleared 510(K)
- P800063CEA-ROCHE TEST KIT2PMA Approval
- P800063CEA-ROCHE TEST KIT2PMA Approval
- P800063CEA-ROCHE TEST KIT2PMA Approval
- K820298CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV2Cleared 510(K)
- P800005ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA2PMA Approval
- P800063CEA-ROCHE TEST KIT2PMA Approval
- P800056ABBOTT CEA-EIA TEST KIT2PMA Approval
- K812658CEA CONTROL PLASMA2Cleared 510(K)
- P800005ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA2PMA Approval
- K810459THREE LEVEL CONTROL SERA2Cleared 510(K)
- K811394CEA DESALTING DOLUMN SEPHADEX R2Cleared 510(K)
- K810810AMICON ULTRAFILTRATION MEMBRANES CMII2Cleared 510(K)
- P800056CEA--RIA DIXGNOSTIC TEST KIT2PMA Approval
- P800005ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA2PMA Approval
- P800005CEA-RIA DIAGNOSTIC TEST KIT2PMA Approval
- P800056CEA-EIA DIAGNOSTIC TEST KIT2PMA Approval
- K801306CLINETICS PCA COLUMN2Cleared 510(K)
- K792377CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL2Cleared 510(K)
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer2Product Code
- 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 CEA IMMUNORADIOMETRIC ASSAY
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- HYBRITECH, INC.
- Trade Name
- TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY
- Generic Name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Decision Date
- 1/13/1994
- Days to Decision
- 414 days
- Decision Code
- APPR
- FDA Decision
- Approval