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Labone, Inc.
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LABONE MICRO-PLATE COTININE EIA is an FDA 510(k)-cleared medical device (K033601) manufactured by Labone, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2004. Regulation: 8.