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 |
| K233060 | Roche Diagnostics | Elecsys Folate III | 06/17/2024 |
| 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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