510(k) K143502

Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls by Immunalysis Corporation — Product Code DJG

K143502 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls". The FDA issued a decision of Substantially Equivalent on May 20, 2015. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Immunalysis Corporation has at least 10 other 510(k) clearances on record.