VITEK 2 AST - YEAST FLUCONAZOLE

VITEK 2 AST - YEAST FLUCONAZOLE is an FDA 510(k)-cleared medical device (K133817) 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 August 4, 2014. Regulation: 8.