BD MAX Extended Enteric Bacterial Panel, BD MAX System

BD MAX Extended Enteric Bacterial Panel, BD MAX System is an FDA 510(k)-cleared medical device (K170308) manufactured by Becton, Dickinson and Company. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2017. Regulation: 8.