510(k) K142855

Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) by Omega Laboratories, Inc. — Product Code DKZ

K142855 is an FDA 510(k) premarket notification submitted by Omega Laboratories, Inc. for the device "Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)". The FDA issued a decision of Substantially Equivalent on July 28, 2015. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Omega Laboratories, Inc. has at least 8 other 510(k) clearances on record.