GC II AGAR WITH ISOVITALEX

GC II AGAR WITH ISOVITALEX is an FDA 510(k)-cleared medical device (K932882) manufactured by Becton Dickinson Microbiology Systems. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 1993. Regulation: 8.