GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS

GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS is an FDA 510(k)-cleared medical device (K883076) 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 September 6, 1988. Regulation: 8.