K143720 is an FDA 510(k) clearance for the Dimension Vista MMB Assay. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on September 18, 2015, 263 days after receiving the submission on December 29, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K143720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2014 |
| Decision Date | September 18, 2015 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHY — Colorimetric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |