BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML is an FDA 510(k)-cleared medical device (K062945) 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 November 20, 2006. Regulation: 8.