510(k) K991447 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Jun 11, 1999 |
| Received | Apr 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991447
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.