Product code CGN
- Device name
- Acid, Folic, Radioimmunoassay
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1295
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233060 | Elecsys Folate III | Roche Diagnostics | 2024-06-17 |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | 2023-08-23 |
| K192586 | LIAISON® Folate | DiaSorin, Inc. | 2020-05-06 |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | 2018-04-12 |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | Diazyme Laboratories | 2016-11-04 |
| K141426 | ELECSYS FOLATE III | Roche Diagnostics | 2014-10-17 |
| K103716 | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET | Roche Diagnostics | 2011-05-12 |
| K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 | Abbott Laboratories | 2010-03-05 |
| K091332 | AIA-PACK RBC FOLATE | Tosoh Bioscience, Inc. | 2009-10-02 |
| K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS | Roche Diagnostics Corp. | 2009-06-19 |
| K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 | Beckman Coulter, Inc. | 2006-04-21 |
| K051292 | ELECSYS RBC FOLATE HEMOLYZED REAGENT | Roche Diagnostics Corp. | 2005-06-17 |
| K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY | Roche Diagnostics Corp. | 2004-12-23 |
| K031756 | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY | Roche Diagnostics Corp. | 2003-06-25 |
| K023397 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | 2002-12-16 |
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | Bayer Diagnostics Corp. | 2001-02-05 |
| 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 |
| K993254 | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 | Diagnostic Products Corp. | 1999-11-12 |
| K992365 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | 1999-08-10 |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Chiron Diagnostics Corp. | 1999-06-30 |
| K984301 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | 1999-02-05 |
| K984166 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 | Ortho-Clinical Diagnostics, Inc. | 1999-02-05 |
| K981931 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-08-25 |
| K972232 | ABBOTT AXSYM FOLATE | Abbott Laboratories | 1997-06-24 |
| K964349 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | 1996-11-27 |
| K960800 | CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) | Boehringer Mannheim Corp. | 1996-07-26 |
| K955434 | ACCESS FOLATE ASSAY (MODIFICATION) | Beckman Coulter, Inc. | 1996-01-29 |
| K954332 | RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-01-24 |
| K951155 | CEDIA FOLATE (NO BOIL) ASSAY | Microgenics Corp. | 1995-06-29 |
| K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | 1995-05-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414293653 | Atellica IM Fol | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00380740136567 | Alinity | ABBOTT IRELAND | 2019-02-12 |
| 00816870022017 | Folate AccuLite CLIA Test System -192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022000 | Folate AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020334 | Monobind AccuBind Folate ELISA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020327 | Folate AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 04015630939695 | Elecsys Folate | Roche Diagnostics GmbH | 2017-04-21 |
| 00817830022542 | SimulTRAC-S Vitamin B12/Folate 125I RIA Kit | MP BIOMEDICALS, LLC | 2016-10-20 |
| 00842768016653 | Dimension Vista® Flex® reagent cartridge FOL | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04560189212046 | AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2016-09-24 |
| 04560189212039 | AIA-PACK RBC FOLATE PRETREATMENT SET | TOSOH CORPORATION | 2016-09-24 |
| 04560189212022 | AIA-PACK RBC FOLATE HEMOLYZING REAGENT SET | TOSOH CORPORATION | 2016-09-24 |
| 14560189211916 | AIA-PACK Folate | TOSOH CORPORATION | 2016-09-24 |
| 14560189212005 | AIA-PACK RBC FOLATE | TOSOH CORPORATION | 2016-09-24 |
| 04560189212015 | AIA-PACK RBC FOLATE CALIBRATOR SET | TOSOH CORPORATION | 2016-09-24 |
| 04560189211926 | AIA-PACK Folate Calibrator Set | TOSOH CORPORATION | 2016-09-24 |
| 04560189211933 | AIA-PACK Folate Pretreatment Set | TOSOH CORPORATION | 2016-09-24 |
| 04560189211940 | AIA-PACK Floate Sample Diluting Solution | TOSOH CORPORATION | 2016-09-24 |
| 04015630938995 | Elecsys Folate RBC Hemolyzing Reagent | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630938988 | Elecsys Folate RBC Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630938964 | Elecsys Folate III | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630943258 | Elecsys Folate III Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 15099590201685 | Access Red Blood Cell Folate Lysing Agent | Beckman Coulter, Inc. | 2016-09-09 |
| 00380740002091 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 15099590209308 | Access Folate | Beckman Coulter, Inc. | 2016-09-09 |
| 00380740002114 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740002138 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 00380740002176 | ARCHITECT | ABBOTT IRELAND | 2016-09-09 |
| 10758750008407 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750009237 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |