K160570 is an FDA 510(k) clearance for the Creatine Kinase. This device is classified as a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHS).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on May 25, 2016, 86 days after receiving the submission on February 29, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K160570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2016 |
| Decision Date | May 25, 2016 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |