510(k) K122759

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) by Omega Laboratories, Inc. — Product Code LDJ

K122759 is an FDA 510(k) premarket notification submitted by Omega Laboratories, Inc. for the device "OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)". The FDA issued a decision of Substantially Equivalent on December 5, 2012. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Omega Laboratories, Inc. has at least 8 other 510(k) clearances on record.