510(k) K011813

AMEDITECH IMMUTEST DRUG SCREEN THC by Ameditech, Inc. — Product Code LDJ

K011813 is an FDA 510(k) premarket notification submitted by Ameditech, Inc. for the device "AMEDITECH IMMUTEST DRUG SCREEN THC". The FDA issued a decision of Substantially Equivalent on October 22, 2001. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Ameditech, Inc. has at least 10 other 510(k) clearances on record.