510(k) K803168 ยท JHW U.V. Method, Cpk Isoenzymes
CARDIO ZYME PLUS CK-MB #65045
| Applicant | Harleco, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 9, 1981 |
| Received | Dec 15, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803168
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.