510(k) K011162

MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY by Syva Co., Dade Behring, Inc. — Product Code DIO

K011162 is an FDA 510(k) premarket notification submitted by Syva Co., Dade Behring, Inc. for the device "MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY". The FDA issued a decision of Substantially Equivalent on May 2, 2001. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Syva Co., Dade Behring, Inc. has at least 10 other 510(k) clearances on record.