510(k) K140671

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE by Omega Laboratories, Inc. — Product Code DJG

K140671 is an FDA 510(k) premarket notification submitted by Omega Laboratories, Inc. for the device "OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE". The FDA issued a decision of Substantially Equivalent on January 8, 2015. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Omega Laboratories, Inc. has at least 8 other 510(k) clearances on record.