510(k) K103161

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

K103161 is an FDA 510(k) premarket notification submitted by Omega Laboratories, Inc. for the device "OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES". The FDA issued a decision of Substantially Equivalent on December 13, 2011. 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.