510(k) K143500

Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set by Immunalysis Corporation — Product Code DKZ

K143500 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set". The FDA issued a decision of Substantially Equivalent on February 6, 2015. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Immunalysis Corporation has at least 10 other 510(k) clearances on record.