510(k) K873171 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Sep 29, 1987 |
| Received | Aug 11, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873171
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.