K102706 is an FDA 510(k) clearance for the CKMB UDR ASSAY. This device is classified as a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHS).
Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on August 19, 2011, 333 days after receiving the submission on September 20, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K102706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2010 |
| Decision Date | August 19, 2011 |
| Days to Decision | 333 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 |