510(k) K002264

BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST by Branan Medical Corporation — Product Code DIO

K002264 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST". The FDA issued a decision of Substantially Equivalent on November 27, 2000. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Branan Medical Corporation has at least 10 other 510(k) clearances on record.