510(k) K161714

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators by Immunalysis Corporation — Product Code DIS

K161714 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators". The FDA issued a decision of Substantially Equivalent on October 14, 2016. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Immunalysis Corporation has at least 10 other 510(k) clearances on record.