510(k) K854708 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
DART CK-MB REAGENT SYSTEM
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Dec 30, 1985 |
| Received | Nov 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854708
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.