510(k) K062929

QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA by Quest Diagnostics, Inc. — Product Code DIO

K062929 is an FDA 510(k) premarket notification submitted by Quest Diagnostics, Inc. for the device "QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA". The FDA issued a decision of Substantially Equivalent on December 18, 2006. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Quest Diagnostics, Inc. has at least 6 other 510(k) clearances on record.