510(k) K904866 ยท JHT Chromatographic Separation, Cpk Isoenzymes
COULTER CK-MB ISOENZYME REAGENT
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Dec 13, 1990 |
| Received | Oct 29, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904866
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.