K133156 is an FDA 510(k) clearance for the ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 24, 2014, 280 days after receiving the submission on October 17, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K133156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2013 |
| Decision Date | July 24, 2014 |
| Days to Decision | 280 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 |