510(k) K030113

MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 by Branan Medical Corp. — Product Code DJG

K030113 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23". The FDA issued a decision of Substantially Equivalent on July 2, 2003. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Branan Medical Corp. has at least 10 other 510(k) clearances on record.