510(k) K981474 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, May 7, 1998 |
| Received | Apr 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981474
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.