510(k) K852483 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jul 12, 1985 |
| Received | Jun 11, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852483
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.