K162526 is an FDA 510(k) clearance for the Creatine Kinase-MB. This device is classified as a U.v. Method, Cpk Isoenzymes (Class II - Special Controls, product code JHW).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 26, 2017, 259 days after receiving the submission on September 9, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K162526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2016 |
| Decision Date | May 26, 2017 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHW — U.v. Method, Cpk Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |