GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL

GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL is an FDA 510(k)-cleared medical device (K874876) manufactured by Baxter Healthcare Corp. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 1988. Regulation: 8.