510(k) K771389 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CK-1 ULTRAZYME PLUS
| Applicant | Harleco, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 2, 1977 |
| Received | Jul 27, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771389
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.