510(k) K801318 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 14, 1980 |
| Received | Jun 8, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801318
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.