K140404 is an FDA 510(k) clearance for the ELECSYS CK-MB STAT IMMUNOASSAY. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 8, 2014, 79 days after receiving the submission on February 18, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K140404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2014 |
| Decision Date | May 08, 2014 |
| Days to Decision | 79 days |
| Submission Type | Special |
| 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 |