FDA 510(k) Applications for Medical Device Product Code "DHX"
(System, Test, Carcinoembryonic Antigen)

FDA 510(k) Number Applicant Device Name Decision Date
K990774 ABBOTT LABORATORIES ABBOTT ARCHITECT CEA 05/11/1999
K810810 AMICON, INC. AMICON ULTRAFILTRATION MEMBRANES CMII 04/17/1981
K013568 BAYER CORP. CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM 12/21/2001
K810459 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC THREE LEVEL CONTROL SERA 08/03/1981
K991707 BECKMAN MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 06/01/1999
K031270 BECKMAN COULTER, INC. ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS 05/06/2003
K981985 BECKMAN COULTER, INC. ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 09/24/1998
K080194 BIOMERIEUX, INC. VIDAS CEA (S) ASSAY 10/09/2008
K833318 BIOSAN LABORATORIES, INC. NORMAL GOAT SERUM 01/03/1984
K980887 BOEHRINGER MANNHEIM CORP. ELECSYS CEA ON THE ELECSYS 1010 06/29/1998
K981478 CHIRON DIAGNOSTICS CORP. ACS:CENTAUR CEA 08/12/1998
K864877 CIBA CORNING DIAGNOSTICS CORP. TRI-LEVEL LIGAND CONTROL 05/21/1987
K801306 CLINETICS CORP. CLINETICS PCA COLUMN 09/26/1980
K071603 DADE BEHRING, INC. DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) 06/25/2008
K970877 DIAGNOSTIC PRODUCTS CORP. IMMULITE CEA 09/22/1997
K980855 DPC CIRRUS IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT 04/21/1998
K792377 ENVIRONMENTAL CHEMICAL SPECIALTIES CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL 09/26/1980
K811394 IMMUNO-DIAGNOSTIC LABORATORIES CEA DESALTING DOLUMN SEPHADEX R 06/12/1981
K081615 OLYMPUS AMERICA, INC. OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN 03/18/2009
K990943 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK 06/01/1999
K041322 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS 06/17/2004
K812658 PACIFIC HEMOSTASIS CEA CONTROL PLASMA 09/29/1981
K924857 TOSOH MEDICS, INC. AIA-PACK CEA CALIBRATION VERIFICATION TEST SET 03/18/1993
K023893 TOSOH MEDICS, INC. ST AIA-PACK CEA ENZYME IMMUNOASSAY 12/18/2002
K820298 VENTREX LABORATORIES, INC. CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV 04/08/1982


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact