
Biosite Incorporated
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TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 is an FDA 510(k)-cleared medical device (K060788) manufactured by Biosite Incorporated. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 9, 2006. Regulation: 8.