510(k) K040092

AMEDITECH IMMU TEST DRUG SCREEN PANEL by Ameditech, Inc. — Product Code DKZ

K040092 is an FDA 510(k) premarket notification submitted by Ameditech, Inc. for the device "AMEDITECH IMMU TEST DRUG SCREEN PANEL". The FDA issued a decision of Substantially Equivalent on March 8, 2004. 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.