510(k) K821464 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CARDIOZYME PLUS CK-MB, #65045
| Applicant | Emd Chemicals, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 2, 1982 |
| Received | May 18, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821464
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.