510(k) K001197

COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA by OraSure Technologies, Inc. — Product Code DIO

K001197 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA". The FDA issued a decision of Substantially Equivalent on May 11, 2000. 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.