The following data is part of a premarket notification filed by Vysis with the FDA for Modification To Vysis Urovysion Bladder Cancer Recurrence Test.
| Device ID | K033982 |
| 510k Number | K033982 |
| Device Name: | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST |
| Classification | System, Test, Tumor Marker, Monitoring, Bladder |
| Applicant | VYSIS 3100 WOODCREEK DRIVE Downers Grove, IL 60515 -5400 |
| Contact | Kerry J Flom |
| Correspondent | Kerry J Flom VYSIS 3100 WOODCREEK DRIVE Downers Grove, IL 60515 -5400 |
| Product Code | MMW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-01-22 |
| Summary: | summary |