510(k) K040198

LABONE COCAINE METABOLITE MICRO-PLATE EIA by Labone, Inc. — Product Code DIO

K040198 is an FDA 510(k) premarket notification submitted by Labone, Inc. for the device "LABONE COCAINE METABOLITE MICRO-PLATE EIA". The FDA issued a decision of Substantially Equivalent on March 5, 2004. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Labone, Inc. has at least 1 other 510(k) clearance on record.