GC BASE W/ 1% GCHI

GC BASE W/ 1% GCHI is an FDA 510(k)-cleared medical device (K954986) manufactured by Remel, L.P.. 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 15, 1996. Regulation: 8.