FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD

About This 510(k) Submission

K082508 is an FDA 510(k) clearance for the FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Branan Medical Corporation (Irvine, US). The FDA issued a Cleared decision on November 21, 2008, 84 days after receiving the submission on August 29, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.