510(k) clearances for System, Test, Carcinoembryonic Antigen
28 on file
- Beckman Coulter, Inc.Sep 22, 2023
K223921 · Access CEA
- Ortho Clinical DiagnosticsAug 23, 2023
K231517 · VITROS Immunodiagnostic Products CEA Reagent Pack
- Siemens Healthcare Disgnostics, Inc.Apr 13, 2020
K200215 · ADVIA Centaur CEA Assay
- Olympus America, Inc.Mar 18, 2009
K081615 · OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
- bioMerieux, Inc.Oct 9, 2008
K080194 · VIDAS CEA (S) ASSAY
- Dade Behring, Inc.Jun 25, 2008
K071603 · DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
- Ortho-Clinical Diagnostics, Inc.Jun 17, 2004
K041322 · VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
- Beckman Coulter, Inc.May 6, 2003
K031270 · ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
- Tosoh Medics, Inc.Dec 18, 2002
K023893 · ST AIA-PACK CEA ENZYME IMMUNOASSAY
- Bayer Corp.Dec 21, 2001
K013568 · CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- BeckmanJun 1, 1999
K991707 · MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
- Ortho-Clinical Diagnostics, Inc.Jun 1, 1999
K990943 · VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
- Abbott LaboratoriesMay 11, 1999
K990774 · ABBOTT ARCHITECT CEA
- Beckman Coulter, Inc.Sep 24, 1998
K981985 · ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
- Chiron Diagnostics Corp.Aug 12, 1998
K981478 · ACS:CENTAUR CEA
- Boehringer Mannheim Corp.Jun 29, 1998
K980887 · ELECSYS CEA ON THE ELECSYS 1010
- Dpc CirrusApr 21, 1998
K980855 · IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
- Diagnostic Products Corp.Sep 22, 1997
K970877 · IMMULITE CEA
- Tosoh Medics, Inc.Mar 18, 1993
K924857 · AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
- Ciba Corning Diagnostics Corp.May 21, 1987
K864877 · TRI-LEVEL LIGAND CONTROL
- Biosan Laboratories, Inc.Jan 3, 1984
K833318 · NORMAL GOAT SERUM
- Ventrex Laboratories, Inc.Apr 8, 1982
K820298 · CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV
- Pacific HemostasisSep 29, 1981
K812658 · CEA CONTROL PLASMA
- Bd Becton Dickinson Vacutainer Systems PreanalyticAug 3, 1981
K810459 · THREE LEVEL CONTROL SERA
- Immuno-Diagnostic LaboratoriesJun 12, 1981
K811394 · CEA DESALTING DOLUMN SEPHADEX R
- Amicon, Inc.Apr 17, 1981
K810810 · AMICON ULTRAFILTRATION MEMBRANES CMII
- Clinetics Corp.Sep 26, 1980
K801306 · CLINETICS PCA COLUMN
- Environmental Chemical SpecialtiesSep 26, 1980
K792377 · CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL