510(k) K973126 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 6, 1997 |
| Received | Aug 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973126
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.