VITEK 2 AST-YS FLUCONAZOLE

VITEK 2 AST-YS FLUCONAZOLE is an FDA 510(k)-cleared medical device (K061945) manufactured by bioMerieux, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 18, 2006. Regulation: 8.