
Biosite Incorporated
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BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML) is an FDA 510(k)-cleared medical device (K931598) manufactured by Biosite Incorporated. 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 May 11, 1993. Regulation: 8.