MALDI Biotyper CA System

MALDI Biotyper CA System is an FDA 510(k)-cleared medical device (K142677) manufactured by Bruker Daltonics, 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 March 26, 2015. Regulation: 8.