FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K990774 |
ABBOTT LABORATORIES |
ABBOTT ARCHITECT CEA |
05/11/1999 |
K013568 |
BAYER CORP. |
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
12/21/2001 |
K991707 |
BECKMAN |
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 |
06/01/1999 |
K223921 |
Beckman Coulter, Inc |
Access CEA |
09/22/2023 |
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 |
K980887 |
BOEHRINGER MANNHEIM CORP. |
ELECSYS CEA ON THE ELECSYS 1010 |
06/29/1998 |
K981478 |
CHIRON DIAGNOSTICS CORP. |
ACS:CENTAUR CEA |
08/12/1998 |
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 |
K081615 |
OLYMPUS AMERICA, INC. |
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN |
03/18/2009 |
K231517 |
Ortho Clinical Diagnostics |
VITROS Immunodiagnostic Products CEA Reagent Pack |
08/23/2023 |
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 |
K200215 |
Siemens Healthcare Disgnostics Inc. |
ADVIA Centaur CEA Assay |
04/13/2020 |
K023893 |
TOSOH MEDICS, INC. |
ST AIA-PACK CEA ENZYME IMMUNOASSAY |
12/18/2002 |