FDA 510(k) Applications for Medical Device Product Code "CGN"
(Acid, Folic, Radioimmunoassay)

FDA 510(k) Number Applicant Device Name Decision Date
K792167 ABBOTT LABORATORIES 125 I FOLATE SOLID PHASE RADIOASSAY 11/13/1979
K984301 ABBOTT LABORATORIES ABBOTT ARCHITECT FOLATE 02/05/1999
K023397 ABBOTT LABORATORIES ABBOTT ARCHITECT FOLATE 12/16/2002
K972232 ABBOTT LABORATORIES ABBOTT AXSYM FOLATE 06/24/1997
K092740 ABBOTT LABORATORIES ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 03/05/2010
K943691 ABBOTT MFG., INC. IMX FOLATE 03/23/1995
K760207 AMERSHAM CORP. KIT, FOLATE RADIOASSAY SC.7 07/26/1976
K812979 AMERSHAM CORP. VITAMIN B12/FOLATE DUAL RADIOASSAY KITS 11/24/1981
K923286 BAXTER DIAGNOSTICS, INC. STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY 09/17/1992
K954332 BAYER CORP. RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM 01/24/1996
K010050 BAYER DIAGNOSTICS CORP. ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY 02/05/2001
K780557 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FOLATE REAGENT KIT, ARIA-II SYSTEM 05/18/1978
K822728 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SOLID PHASE SIMUL TRAC VITAMIN B12 11/05/1982
K932887 BECKMAN COULTER, INC. ACCESS FOLATE ASSAY 10/12/1993
K955434 BECKMAN COULTER, INC. ACCESS FOLATE ASSAY (MODIFICATION) 01/29/1996
K943149 BECKMAN COULTER, INC. ACCESS RED BLOOD CELL FOLATE ASSAY 08/26/1994
K060774 BECKMAN COULTER, INC. FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 04/21/2006
K760133 BIO-RAD PROCEDURE, RED CELL FOLATE ASSAY 07/20/1976
K811177 BIO-RAD QUANTA PHASE VITAMIN B-12/FOLATE RAD 05/15/1981
K935286 BIO-RAD QUANTAPHASE II B12/FOLATE 02/18/1994
K933571 BIO-RAD RADIAS FOLATE ENZYME IMMUNOASSAY 10/01/1993
K944212 BIO-RAD RADIAS RED CELL FOLATE IMMUNOASAY 02/03/1995
K922823 BIO-RAD LABORATORIES, INC. ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS 08/05/1992
K960800 BOEHRINGER MANNHEIM CORP. CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) 07/26/1996
K801198 CALBIOCHEM-BEHRING CORP. FOLATE RADIOASSAY KIT 07/21/1980
K991582 CHIRON DIAGNOSTICS CORP. CHIRON DIAGNOSTICS ACS: 180 FOLATE 06/30/1999
K943297 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS FOLATE ASSAY 12/12/1994
K893684 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY 07/27/1989
K832712 CLINICAL ASSAYS, INC. FOLATE RADIOASSAY KIT CA-1562-125 10/04/1983
K791079 CLINICAL ASSAYS, INC. GAMMADAB (125 1) FOLATE RADIOASSAY KIT 07/17/1979
K771597 CLINICAL ASSAYS, INC. IN VITRO FOLATE RADIOASSAY KIT 09/13/1977
K803060 CORNING MEDICAL & SCIENTIFIC FOLATE 125I RADIOIMMUNOASSAY 12/22/1980
K841302 DIAGNON CORP. DIAGNON FOLATE 125I RIA KIT 06/22/1984
K810001 DIAGNOSTIC PRODUCTS CORP. 'NO-BOIL' DUALCOUNT KIT 01/16/1981
K943705 DIAGNOSTIC PRODUCTS CORP. FOLIC ACID 10/31/1994
K993254 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 11/12/1999
K921614 DIAGNOSTIC PRODUCTS CORP. MILENIA FOLIC ACID 06/25/1992
K760262 DIAMOND SHAMROCK CORP. RADIOASSY KIT, 3H-FOLATE 08/03/1976
K161646 DIAZYME LABORATORIES Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set 11/04/2016
K780508 KALLESTAD LABORATORIES, INC. QUANTITOPE 125I-FOLATE RADIOASSAY KIT 05/03/1978
K951155 MICROGENICS CORP. CEDIA FOLATE (NO BOIL) ASSAY 06/29/1995
K921689 MICROGENICS CORP. CEDIA RED BLOOD CELL FOLATE REAGENT PACK 06/16/1992
K946184 MICROGENICS CORP. CEDIA(R) FOLATE (NO BOIL) ASSAY 01/17/1995
K810186 MICROMEDIC SYSTEMS MICROMEDIC SYSTEMS' AUTOPAK 02/04/1981
K950292 MILES, INC. FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM 05/02/1995
K001266 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA 05/02/2000
K984166 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 02/05/1999
K800914 RIA PRODUCTS, INC. NO-BOIL FOLATE KIT #RP-500 05/08/1980
K780148 RIA PRODUCTS, INC. RIA FOR FOLATES & VIT. B12, COMBO KIT 03/03/1978
K141426 Roche Diagnostics ELECSYS FOLATE III 10/17/2014
K103716 Roche Diagnostics ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET 05/12/2011
K051292 ROCHE DIAGNOSTICS CORP. ELECSYS RBC FOLATE HEMOLYZED REAGENT 06/17/2005
K043318 ROCHE DIAGNOSTICS CORP. MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY 12/23/2004
K031756 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY 06/25/2003
K082340 ROCHE DIAGNOSTICS CORP. ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS 06/19/2009
K981931 ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY 08/25/1998
K172201 Siemens Healthcare Diagnostics Inc. Atellica IM Folate Assay 04/12/2018
K934121 SYVA CO. VISTA FOLATE ASSAY 10/22/1993
K091332 Tosoh BioScience, Inc. AIA-PACK RBC FOLATE 10/02/2009
K992365 TOSOH MEDICS, INC. AIA-PACK FOLATE ASSAY 08/10/1999
K964349 TOSOH MEDICS, INC. AIA-PACK FOLATE ASSAY 11/27/1996


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