UROVYSION BLADDER CANCER RECURRENCE KIT

UROVYSION BLADDER CANCER RECURRENCE KIT is an FDA 510(k)-cleared medical device (K013785) manufactured by Vysis. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 2002. Regulation: 8.