WELLCOZYME HSV WZO2

WELLCOZYME HSV WZO2 is an FDA 510(k)-cleared medical device (K875311) manufactured by Wellcome Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 1988. Regulation: 8.