GCII AGAR WITH ISOVITALX(R) ENRICHMENT

GCII AGAR WITH ISOVITALX(R) ENRICHMENT is an FDA 510(k)-cleared medical device (K945569) 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 February 1, 1995. Regulation: 8.