ERTAPENEM 10UG BBL SENSI-DISC

ERTAPENEM 10UG BBL SENSI-DISC is an FDA 510(k)-cleared medical device (K020842) 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 May 14, 2002. Regulation: 8.