510(k) K113046

AMEDITECH IMMUTEST MILTI-DRUG SCREEN by Ameditech, Inc. — Product Code DKZ

K113046 is an FDA 510(k) premarket notification submitted by Ameditech, Inc. for the device "AMEDITECH IMMUTEST MILTI-DRUG SCREEN". The FDA issued a decision of Substantially Equivalent on November 10, 2011. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Ameditech, Inc. has at least 10 other 510(k) clearances on record.