510(k) K974827 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jan 8, 1998 |
| Received | Dec 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974827
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.