DRIED GRAM-POSITIVE MIC/COMBO PANELS

DRIED GRAM-POSITIVE MIC/COMBO PANELS is an FDA 510(k)-cleared medical device (K943510) 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 December 1, 1994. Regulation: 8.