VITEK 2 AST-ST CEFOTAXIME

VITEK 2 AST-ST CEFOTAXIME is an FDA 510(k)-cleared medical device (K121863) 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 15, 2012. Regulation: 8.