510(k) K142129

RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET by Biophor Diagnostics, Inc. — Product Code DIO

K142129 is an FDA 510(k) premarket notification submitted by Biophor Diagnostics, Inc. for the device "RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET". The FDA issued a decision of Substantially Equivalent on July 24, 2015. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Biophor Diagnostics, Inc. has at least 6 other 510(k) clearances on record.