CDD — Radioassay, Vitamin B12 Class II
FDA product code CDD covers "Radioassay, Vitamin B12", a Class II medical device regulated under 21 CFR 862.1810. 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
- CDD
- Device Class
- Class II
- Regulation Number
- 862.1810
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233541 | axis-shield diagnostics | ARCHITECT Active-B12 (Holotranscobalamin) | July 31, 2024 |
| K223289 | beckman coulter | Access Vitamin B12 | December 23, 2022 |
| K190298 | beckman coulter biomedical | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Acc | October 4, 2019 |
| K192064 | diasorin | LIAISON Vitamin B12 | October 2, 2019 |
| K172133 | axis-shield diagnostics | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | October 27, 2017 |
| K161721 | diazyme laboratories | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin | September 20, 2016 |
| K160757 | axis-shield diagnostics limited | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active- | July 26, 2016 |
| K151786 | roche diagnostics | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | September 24, 2015 |
| K140496 | beckman coulter | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYP | September 16, 2014 |
| K133512 | siemens healthcare diagnostics | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL | January 2, 2014 |
| K121946 | axis-shield diagnostics | AXIS-SHIELD ACVTIVE-B12 | March 22, 2013 |
| K121994 | siemens healthcare diagnostics | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI | November 30, 2012 |
| K111260 | anticancer | A/C ENZYMATIC VITAMIN B6 ASSAY | July 26, 2012 |
| K121314 | abbott laboratories | ARCHITECT B12 | May 17, 2012 |
| K112443 | axis-shield diagnostics | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | December 19, 2011 |
| K110579 | abbott laboratories | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS | October 6, 2011 |
| K110413 | beckman coulter | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS | May 11, 2011 |
| K093631 | siemens healthcare diagnostics | B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 | February 12, 2010 |
| K090588 | beckman coulter | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: | May 27, 2009 |
| K071224 | dade behring | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBR | November 13, 2007 |