510(k) K900806 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Mar 23, 1990 |
| Received | Feb 21, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900806
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.