510(k) K103227

ORATECT ORAL FLUID DRUG SCREEN DEVICES by Branan Medical Corporation — Product Code DIO

K103227 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "ORATECT ORAL FLUID DRUG SCREEN DEVICES". The FDA issued a decision of Substantially Equivalent on April 11, 2012. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Branan Medical Corporation has at least 10 other 510(k) clearances on record.