510(k) K011031 ยท MMW System, Test, Tumor Marker, Monitoring, Bladder
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
| Applicant | Vysis, Downers Grove IL, US |
| Decision | Substantially Equivalent, Aug 3, 2001 |
| Received | Apr 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Vysis ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphobla Terminated |
MMW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.