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 |