510(k) K811576 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
| Applicant | Harleco, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 25, 1981 |
| Received | Jun 4, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811576
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.