510(k) K972687 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
CARDIAC STATUS CONTROLS/TROPONIN I
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Jul 28, 1997 |
| Received | Jul 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972687
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.