510(k) K974461 ยท JJT Enzyme Controls (Assayed And Unassayed)
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 10, 1997 |
| Received | Nov 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974461
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.