510(k) K033982 ยท MMW System, Test, Tumor Marker, Monitoring, Bladder
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
| Applicant | Vysis, Downers Grove IL, US |
| Decision | Substantially Equivalent, Jan 22, 2004 |
| Received | Dec 23, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033982
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.