K151786 is an FDA 510(k) clearance for the Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 24, 2015, 85 days after receiving the submission on July 1, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K151786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2015 |
| Decision Date | September 24, 2015 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDD — Radioassay, Vitamin B12 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |