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bioMerieux, Inc.
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VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE is an FDA 510(k)-cleared medical device (K080201) manufactured by bioMerieux, 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 April 29, 2008. Regulation: 8.