510(k) K964151 ยท MMW System, Test, Tumor Marker, Monitoring, Bladder
BARD AND BTA TEST
| Applicant | Bard Diagnostic Sciences,Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Apr 16, 1997 |
| Received | Oct 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964151
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.