K130080 is an FDA 510(k) clearance for the EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on May 13, 2014, 484 days after receiving the submission on January 14, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K130080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2013 |
| Decision Date | May 13, 2014 |
| Days to Decision | 484 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JHY - Colorimetric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |