510(k) K142293

Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls by Biophor Diagnostics, Inc. — Product Code LAF

K142293 is an FDA 510(k) premarket notification submitted by Biophor Diagnostics, Inc. for the device "Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls". The FDA issued a decision of Substantially Equivalent on September 18, 2015. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Biophor Diagnostics, Inc. has at least 6 other 510(k) clearances on record.