BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE is an FDA 510(k)-cleared medical device (K060324) 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 24, 2006. Regulation: 8.