K113546 is an FDA 510(k) clearance for the ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS 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 July 24, 2012, 236 days after receiving the submission on December 1, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K113546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2011 |
| Decision Date | July 24, 2012 |
| Days to Decision | 236 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 |