K162840 is an FDA 510(k) clearance for the Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 8, 2017, 120 days after receiving the submission on October 11, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K162840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2016 |
| Decision Date | February 08, 2017 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRG — System, Test, Vitamin D |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1825 |