510(k) K082508

FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD by Branan Medical Corporation — Product Code DJG

K082508 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Branan Medical Corporation has at least 10 other 510(k) clearances on record.