510(k) K004034

MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 by Branan Medical Corp. — Product Code DKZ

K004034 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12". The FDA issued a decision of Substantially Equivalent on March 8, 2001. 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.