510(k) K151395

Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets by Immunalysis Corporation — Product Code DJR

K151395 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets". The FDA issued a decision of Substantially Equivalent on July 24, 2015. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Immunalysis Corporation has at least 10 other 510(k) clearances on record.