MERITEC(TM)-GC

MERITEC(TM)-GC is an FDA 510(k)-cleared medical device (K874078) manufactured by Meridian Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 1987. Regulation: 8.