VITEK 2 YEAST CASPOFUNGIN

VITEK 2 YEAST CASPOFUNGIN is an FDA 510(k)-cleared medical device (K101566) 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 27, 2010. Regulation: 8.