510(k) K982759

AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U by OraSure Technologies, Inc. — Product Code DIO

K982759 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U". The FDA issued a decision of Substantially Equivalent on November 20, 1998. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.