510(k) K113501

AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) by Ameditech, Inc. — Product Code DIO

K113501 is an FDA 510(k) premarket notification submitted by Ameditech, Inc. for the device "AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)". The FDA issued a decision of Substantially Equivalent on December 5, 2011. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Ameditech, Inc. has at least 10 other 510(k) clearances on record.