FDA Product Code
FDA Product Code CGN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1295
510(k) Clearances — 64 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233060 | Elecsys Folate III | Roche Diagnostics | 2024-06-17 | Traditional | PDF ↗ |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | 2023-08-23 | Traditional | PDF ↗ |
| K192586 | LIAISON® Folate | DiaSorin, Inc. | 2020-05-06 | Traditional | PDF ↗ |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | 2018-04-12 | Traditional | PDF ↗ |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | Diazyme Laboratories | 2016-11-04 | Traditional | PDF ↗ |
| K141426 | ELECSYS FOLATE III | Roche Diagnostics | 2014-10-17 | Traditional | PDF ↗ |
| K103716 | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET | Roche Diagnostics | 2011-05-12 | Special | PDF ↗ |
| K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 | Abbott Laboratories | 2010-03-05 | Traditional | PDF ↗ |
| K091332 | AIA-PACK RBC FOLATE | Tosoh Bioscience, Inc. | 2009-10-02 | Traditional | PDF ↗ |
| K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS | Roche Diagnostics Corp. | 2009-06-19 | Traditional | PDF ↗ |
| K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 | Beckman Coulter, Inc. | 2006-04-21 | Special | PDF ↗ |
| K051292 | ELECSYS RBC FOLATE HEMOLYZED REAGENT | Roche Diagnostics Corp. | 2005-06-17 | Special | PDF ↗ |
| K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY | Roche Diagnostics Corp. | 2004-12-23 | Special | PDF ↗ |
| K031756 | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY | Roche Diagnostics Corp. | 2003-06-25 | Special | PDF ↗ |
| K023397 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | 2002-12-16 | Traditional | PDF ↗ |
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | Bayer Diagnostics Corp. | 2001-02-05 | Traditional | PDF ↗ |
| K001266 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA | Ortho-Clinical Diagnostics, Inc. | 2000-05-02 | Special | PDF ↗ |
| K993254 | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 | Diagnostic Products Corp. | 1999-11-12 | Traditional | PDF ↗ |
| K992365 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | 1999-08-10 | Traditional | PDF ↗ |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Chiron Diagnostics Corp. | 1999-06-30 | Traditional | PDF ↗ |
| K984301 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | 1999-02-05 | Traditional | PDF ↗ |
| K984166 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 | Ortho-Clinical Diagnostics, Inc. | 1999-02-05 | Traditional | PDF ↗ |
| K981931 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-08-25 | Traditional | PDF ↗ |
| K972232 | ABBOTT AXSYM FOLATE | Abbott Laboratories | 1997-06-24 | Traditional | PDF ↗ |
| K964349 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K960800 | CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) | Boehringer Mannheim Corp. | 1996-07-26 | Traditional | PDF ↗ |
| K955434 | ACCESS FOLATE ASSAY (MODIFICATION) | Beckman Coulter, Inc. | 1996-01-29 | Traditional | PDF ↗ |
| K954332 | RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-01-24 | Traditional | PDF ↗ |
| K951155 | CEDIA FOLATE (NO BOIL) ASSAY | Microgenics Corp. | 1995-06-29 | Traditional | PDF ↗ |
| K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | 1995-05-02 | Traditional | PDF ↗ |
| K943691 | IMX FOLATE | Abbott Mfg., Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K944212 | RADIAS RED CELL FOLATE IMMUNOASAY | Bio-Rad | 1995-02-03 | Traditional | PDF ↗ |
| K946184 | CEDIA(R) FOLATE (NO BOIL) ASSAY | Microgenics Corp. | 1995-01-17 | Traditional | PDF ↗ |
| K943297 | CIBA CORNING ACS FOLATE ASSAY | Ciba Corning Diagnostics Corp. | 1994-12-12 | Traditional | PDF ↗ |
| K943705 | FOLIC ACID | Diagnostic Products Corp. | 1994-10-31 | Traditional | PDF ↗ |
| K943149 | ACCESS RED BLOOD CELL FOLATE ASSAY | Beckman Coulter, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K935286 | QUANTAPHASE II B12/FOLATE | Bio-Rad | 1994-02-18 | Traditional | PDF ↗ |
| K934121 | VISTA FOLATE ASSAY | Syva Co. | 1993-10-22 | Traditional | PDF ↗ |
| K932887 | ACCESS FOLATE ASSAY | Beckman Coulter, Inc. | 1993-10-12 | Traditional | PDF ↗ |
| K933571 | RADIAS FOLATE ENZYME IMMUNOASSAY | Bio-Rad | 1993-10-01 | Traditional | PDF ↗ |
| K923286 | STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY | Baxter Diagnostics, Inc. | 1992-09-17 | Traditional | PDF ↗ |
| K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS | Bio-Rad Laboratories, Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K921614 | MILENIA FOLIC ACID | Diagnostic Products Corp. | 1992-06-25 | Traditional | PDF ↗ |
| K921689 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK | Microgenics Corp. | 1992-06-16 | Traditional | PDF ↗ |
| K893684 | CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1989-07-27 | Traditional | PDF ↗ |
| K841302 | DIAGNON FOLATE 125I RIA KIT | Diagnon Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Clinical Assays, Inc. | 1983-10-04 | Traditional | PDF ↗ |
| K822728 | SOLID PHASE SIMUL TRAC VITAMIN B12 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-11-05 | Traditional | PDF ↗ |
| K812979 | VITAMIN B12/FOLATE DUAL RADIOASSAY KITS | Amersham Corp. | 1981-11-24 | Traditional | PDF ↗ |
| K811177 | QUANTA PHASE VITAMIN B-12/FOLATE RAD | Bio-Rad | 1981-05-15 | Traditional | PDF ↗ |
| K810186 | MICROMEDIC SYSTEMS' AUTOPAK | Micromedic Systems | 1981-02-04 | Traditional | PDF ↗ |
| K810001 | 'NO-BOIL' DUALCOUNT KIT | Diagnostic Products Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K803060 | FOLATE 125I RADIOIMMUNOASSAY | Corning Medical & Scientific | 1980-12-22 | Traditional | PDF ↗ |
| K801198 | FOLATE RADIOASSAY KIT | Calbiochem-Behring Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K800914 | NO-BOIL FOLATE KIT #RP-500 | Ria Products, Inc. | 1980-05-08 | Traditional | PDF ↗ |
| K792167 | 125 I FOLATE SOLID PHASE RADIOASSAY | Abbott Laboratories | 1979-11-13 | Traditional | PDF ↗ |
| K791079 | GAMMADAB (125 1) FOLATE RADIOASSAY KIT | Clinical Assays, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K780557 | FOLATE REAGENT KIT, ARIA-II SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-05-18 | Traditional | PDF ↗ |
| K780508 | QUANTITOPE 125I-FOLATE RADIOASSAY KIT | Kallestad Laboratories, Inc. | 1978-05-03 | Traditional | PDF ↗ |
| K780148 | RIA FOR FOLATES & VIT. B12, COMBO KIT | Ria Products, Inc. | 1978-03-03 | Traditional | PDF ↗ |
| K771597 | IN VITRO FOLATE RADIOASSAY KIT | Clinical Assays, Inc. | 1977-09-13 | Traditional | PDF ↗ |
| K760262 | RADIOASSY KIT, 3H-FOLATE | Diamond Shamrock Corp. | 1976-08-03 | Traditional | PDF ↗ |
| K760207 | KIT, FOLATE RADIOASSAY SC.7 | Amersham Corp. | 1976-07-26 | Traditional | PDF ↗ |
| K760133 | PROCEDURE, RED CELL FOLATE ASSAY | Bio-Rad | 1976-07-20 | Traditional | PDF ↗ |
Product code CGN · Class II · Clinical Chemistry. Data: openFDA.