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

FDA 510(k) Number Applicant Device Name Decision Date
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
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
K223590 Beckman Coulter, Inc. Access Folate Assay 08/23/2023
K955434 BECKMAN COULTER, INC. ACCESS FOLATE ASSAY (MODIFICATION) 01/29/1996
K060774 BECKMAN COULTER, INC. FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 04/21/2006
K960800 BOEHRINGER MANNHEIM CORP. CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) 07/26/1996
K991582 CHIRON DIAGNOSTICS CORP. CHIRON DIAGNOSTICS ACS: 180 FOLATE 06/30/1999
K993254 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 11/12/1999
K192586 Diasorin Inc. LIAISON« Folate 05/06/2020
K161646 DIAZYME LABORATORIES Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set 11/04/2016
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
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
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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