Medical Device Manufacturer · US , Downers Grove , IL

Vysis - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1996

9

Total

8

Cleared

1

Denied

FDA 510(k) Regulatory Record - Vysis Immunology ✕

3 devices

1-3 of 3

Cleared Jan 22, 2004

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST

Immunology · 30d

Cleared Feb 08, 2002

UROVYSION BLADDER CANCER RECURRENCE KIT

Immunology · 86d

Cleared Aug 03, 2001

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

Immunology · 120d