510(k) K971566 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE-MB REAGENT SET
| Applicant | Horizon Diagnostics, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jul 14, 1997 |
| Received | Apr 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971566
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.