510(k) K974845 ยท MMW System, Test, Tumor Marker, Monitoring, Bladder
BTA STAT TEST PRESCRIPTION HOME USE
| Applicant | Bard Diagnostic Sciences,Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 8, 1998 |
| Received | Dec 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974845
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.