510(k) K033743

COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT by Cozart Bioscience , Ltd. — Product Code DKZ

K033743 is an FDA 510(k) premarket notification submitted by Cozart Bioscience , Ltd. for the device "COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT". The FDA issued a decision of Substantially Equivalent on June 3, 2004. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Cozart Bioscience , Ltd. has at least 5 other 510(k) clearances on record.