MALDI BIOTYPER CA (MBT-CA) SYSTEM

MALDI BIOTYPER CA (MBT-CA) SYSTEM is an FDA 510(k)-cleared medical device (K130831) 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 November 20, 2013. Regulation: 8.