510(k) K122752

FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD by Branan Medical Corp. — Product Code JXN

K122752 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD". The FDA issued a decision of Substantially Equivalent on January 30, 2013. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Branan Medical Corp. has at least 10 other 510(k) clearances on record.