
Dade Microscan, Inc.
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DRIED GRAM-POSITIVE MIC/COMBO PANELS is an FDA 510(k)-cleared medical device (K003619) manufactured by Dade Microscan, 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 January 8, 2001. Regulation: 8.