
Biosite Incorporated
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TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS is an FDA 510(k)-cleared medical device (K973784) 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 December 2, 1997. Regulation: 8.