DRIED GRAM-NEGATIVE MIC/COMBO PANELS

DRIED GRAM-NEGATIVE MIC/COMBO PANELS is an FDA 510(k)-cleared medical device (K970676) manufactured by Dade Intl., 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 May 1, 1997. Regulation: 8.