510(k) K141748

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

K141748 is an FDA 510(k) premarket notification submitted by Biophor Diagnostics, Inc. for the device "RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET". The FDA issued a decision of Substantially Equivalent on May 20, 2015. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Biophor Diagnostics, Inc. has at least 6 other 510(k) clearances on record.