510(k) K130080 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
| Applicant | Medica Corporation, Bedford MA, US |
| Decision | Substantially Equivalent, May 13, 2014 |
| Received | Jan 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130080
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.