GRAM NEGATIVE COMBO PANEL TYPE 3

GRAM NEGATIVE COMBO PANEL TYPE 3 is an FDA 510(k)-cleared medical device (K861584) manufactured by American Micro Scan. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 1986. Regulation: 8.