510(k) K992207

QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM by Syntron Bioresearch, Inc. — Product Code DIO

K992207 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1999. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.