510(k) K934340

BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS by Biosite Incorporated — Product Code LFI

K934340 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS". The FDA issued a decision of Substantially Equivalent on December 2, 1994. The device falls under product code LFI (High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Biosite Incorporated has at least 10 other 510(k) clearances on record.