510(k) K070835 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
OLYMPUS CK-MB REAGENT
| Applicant | Olympus Life & Material Science Europa GmbH (Irish, O'Callaghans Mills, Co. Clare, IE |
| Decision | Substantially Equivalent, Jun 4, 2007 |
| Received | Mar 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070835
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.