510(k) K133642

RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK by Biophor Diagnostics, Inc. — Product Code DJG

K133642 is an FDA 510(k) premarket notification submitted by Biophor Diagnostics, Inc. for the device "RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK". The FDA issued a decision of Substantially Equivalent on January 24, 2014. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Biophor Diagnostics, Inc. has at least 6 other 510(k) clearances on record.