510(k) K952250 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 17, 1995 |
| Received | May 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952250
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.