Panels › Clinical Chemistry › Product code CGN · Class 2
Acid, Folic, Radioimmunoassay
Regulation 862.1295
0510(k)s in 12 months (64 all time)
0recalls in 12 months (41 all time)
37recalls that name a 510(k)
Top companies in CGN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2024 | K233060 | Elecsys Folate III Roche Diagnostics | CGN |
| Aug 23, 2023 | K223590 | Access Folate Assay Beckman Coulter, Inc. | CGN |
| May 6, 2020 | K192586 | LIAISON® Folate DiaSorin, Inc. | CGN |
| Apr 12, 2018 | K172201 | Atellica IM Folate Assay Siemens Healthcare Diagnostics, Inc. | CGN |
| Nov 4, 2016 | K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set Diazyme Laboratories | CGN |
| Oct 17, 2014 | K141426 | ELECSYS FOLATE III Roche Diagnostics | CGN |
| May 12, 2011 | K103716 | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET Roche Diagnostics | CGN |
| Mar 5, 2010 | K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 Abbott Laboratories | CGN |
| Oct 2, 2009 | K091332 | AIA-PACK RBC FOLATE Tosoh Bioscience, Inc. | CGN |
| Jun 19, 2009 | K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS Roche Diagnostics Corp. | CGN |
| Apr 21, 2006 | K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 Beckman Coulter, Inc. | CGN |
| Jun 17, 2005 | K051292 | ELECSYS RBC FOLATE HEMOLYZED REAGENT Roche Diagnostics Corp. | CGN |
| Dec 23, 2004 | K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY Roche Diagnostics Corp. | CGN |
| Jun 25, 2003 | K031756 | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY Roche Diagnostics Corp. | CGN |
| Dec 16, 2002 | K023397 | ABBOTT ARCHITECT FOLATE Abbott Laboratories | CGN |
| Feb 5, 2001 | K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY Bayer Diagnostics Corp. | CGN |
| May 2, 2000 | K001266 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA Ortho-Clinical Diagnostics, Inc. | CGN |
| Nov 12, 1999 | K993254 | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 Diagnostic Products Corp. | CGN |
| Aug 10, 1999 | K992365 | AIA-PACK FOLATE ASSAY Tosoh Medics, Inc. | CGN |
| Jun 30, 1999 | K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE Chiron Diagnostics Corp. | CGN |
| Feb 5, 1999 | K984301 | ABBOTT ARCHITECT FOLATE Abbott Laboratories | CGN |
| Feb 5, 1999 | K984166 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 Ortho-Clinical Diagnostics, Inc. | CGN |
| Aug 25, 1998 | K981931 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY Roche Diagnostics/Boehringer Mannheim GmbH | CGN |
| Jun 24, 1997 | K972232 | ABBOTT AXSYM FOLATE Abbott Laboratories | CGN |
| Nov 27, 1996 | K964349 | AIA-PACK FOLATE ASSAY Tosoh Medics, Inc. | CGN |
| Jul 26, 1996 | K960800 | CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) Boehringer Mannheim Corp. | CGN |
| Jan 29, 1996 | K955434 | ACCESS FOLATE ASSAY (MODIFICATION) Beckman Coulter, Inc. | CGN |
| Jan 24, 1996 | K954332 | RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM Bayer Corp. | CGN |
| Jun 29, 1995 | K951155 | CEDIA FOLATE (NO BOIL) ASSAY Microgenics Corp. | CGN |
| May 2, 1995 | K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM Miles, Inc. | CGN |
| Mar 23, 1995 | K943691 | IMX FOLATE Abbott Mfg., Inc. | CGN |
| Feb 3, 1995 | K944212 | RADIAS RED CELL FOLATE IMMUNOASAY Bio-Rad | CGN |
| Jan 17, 1995 | K946184 | CEDIA(R) FOLATE (NO BOIL) ASSAY Microgenics Corp. | CGN |
| Dec 12, 1994 | K943297 | CIBA CORNING ACS FOLATE ASSAY Ciba Corning Diagnostics Corp. | CGN |
| Oct 31, 1994 | K943705 | FOLIC ACID Diagnostic Products Corp. | CGN |
| Aug 26, 1994 | K943149 | ACCESS RED BLOOD CELL FOLATE ASSAY Beckman Coulter, Inc. | CGN |
| Feb 18, 1994 | K935286 | QUANTAPHASE II B12/FOLATE Bio-Rad | CGN |
| Oct 22, 1993 | K934121 | VISTA FOLATE ASSAY Syva Co. | CGN |
| Oct 12, 1993 | K932887 | ACCESS FOLATE ASSAY Beckman Coulter, Inc. | CGN |
| Oct 1, 1993 | K933571 | RADIAS FOLATE ENZYME IMMUNOASSAY Bio-Rad | CGN |
| Sep 17, 1992 | K923286 | STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY Baxter Diagnostics, Inc. | CGN |
| Aug 5, 1992 | K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS Bio-Rad Laboratories, Inc. | CGN |
| Jun 25, 1992 | K921614 | MILENIA FOLIC ACID Diagnostic Products Corp. | CGN |
| Jun 16, 1992 | K921689 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK Microgenics Corp. | CGN |
| Jul 27, 1989 | K893684 | CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY Ciba Corning Diagnostics Corp. | CGN |
| Jun 22, 1984 | K841302 | DIAGNON FOLATE 125I RIA KIT Diagnon Corp. | CGN |
| Oct 4, 1983 | K832712 | FOLATE RADIOASSAY KIT CA-1562-125 Clinical Assays, Inc. | CGN |
| Nov 5, 1982 | K822728 | SOLID PHASE SIMUL TRAC VITAMIN B12 Bd Becton Dickinson Vacutainer Systems Preanalytic | CGN |
| Nov 24, 1981 | K812979 | VITAMIN B12/FOLATE DUAL RADIOASSAY KITS Amersham Corp. | CGN |
| May 15, 1981 | K811177 | QUANTA PHASE VITAMIN B-12/FOLATE RAD Bio-Rad | CGN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.