510(k) K150925

Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set by Immunalysis Corporation — Product Code DIO

K150925 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set". The FDA issued a decision of Substantially Equivalent on June 29, 2015. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Immunalysis Corporation has at least 10 other 510(k) clearances on record.