BACTEC MGIT 960 PZA KIT

BACTEC MGIT 960 PZA KIT is an FDA 510(k)-cleared medical device (K021582) manufactured by Becton, Dickinson & CO. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2002. Regulation: 8.