CGN — Acid, Folic, Radioimmunoassay Class II
FDA product code CGN covers "Acid, Folic, Radioimmunoassay", a Class II medical device regulated under 21 CFR 862.1295. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGN
- Device Class
- Class II
- Regulation Number
- 862.1295
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233060 | roche diagnostics | Elecsys Folate III | June 17, 2024 |
| K223590 | beckman coulter | Access Folate Assay | August 23, 2023 |
| K192586 | diasorin | LIAISON® Folate | May 6, 2020 |
| K172201 | siemens healthcare diagnostics | Atellica IM Folate Assay | April 12, 2018 |
| K161646 | diazyme laboratories | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | November 4, 2016 |
| K141426 | roche diagnostics | ELECSYS FOLATE III | October 17, 2014 |
| K103716 | roche diagnostics | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET | May 12, 2011 |
| K092740 | abbott laboratories | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CO | March 5, 2010 |
| K091332 | tosoh bioscience | AIA-PACK RBC FOLATE | October 2, 2009 |
| K082340 | roche diagnostics | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELE | June 19, 2009 |
| K060774 | beckman coulter | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 | April 21, 2006 |
| K051292 | roche diagnostics | ELECSYS RBC FOLATE HEMOLYZED REAGENT | June 17, 2005 |
| K043318 | roche diagnostics | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY | December 23, 2004 |
| K031756 | roche diagnostics | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY | June 25, 2003 |
| K023397 | abbott laboratories | ABBOTT ARCHITECT FOLATE | December 16, 2002 |
| K010050 | bayer diagnostics | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | February 5, 2001 |
| K001266 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REA | May 2, 2000 |
| K993254 | diagnostic products | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 | November 12, 1999 |
| K992365 | tosoh medics | AIA-PACK FOLATE ASSAY | August 10, 1999 |
| K991582 | chiron diagnostics | CHIRON DIAGNOSTICS ACS: 180 FOLATE | June 30, 1999 |