The following data is part of a premarket notification filed by Vysis with the FDA for Urovysion Bladder Cancer Recurrence Kit.
| Device ID | K013785 |
| 510k Number | K013785 |
| Device Name: | UROVYSION BLADDER CANCER RECURRENCE KIT |
| Classification | System, Test, Tumor Marker, Monitoring, Bladder |
| Applicant | VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515 |
| Product Code | MMW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-14 |
| Decision Date | 2002-02-08 |
| Summary: | summary |