510(k) K151203

Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set by Immunalysis Corporation — Product Code LDJ

K151203 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set". The FDA issued a decision of Substantially Equivalent on June 5, 2015. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Immunalysis Corporation has at least 10 other 510(k) clearances on record.