510(k) K040203

MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 by Branan Medical Corp. — Product Code DKZ

K040203 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22". The FDA issued a decision of Substantially Equivalent on March 25, 2004. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Branan Medical Corp. has at least 10 other 510(k) clearances on record.