MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL

MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL is an FDA 510(k)-cleared medical device (K922482) manufactured by Baxter 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 March 11, 1993. Regulation: 8.