510(k) K002266

BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST by Branan Medical Corporation — Product Code DKZ

K002266 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST". The FDA issued a decision of Substantially Equivalent on November 22, 2000. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Branan Medical Corporation has at least 10 other 510(k) clearances on record.