GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS

GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS is an FDA 510(k)-cleared medical device (K894146) 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 4, 1989. Regulation: 8.