510(k) K181553

Immunalysis Ethyl Alcohol Enzyme Assay by Immunalysis Corporation — Product Code DIC

K181553 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Ethyl Alcohol Enzyme Assay". The FDA issued a decision of Substantially Equivalent on October 31, 2018. The device falls under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Immunalysis Corporation has at least 10 other 510(k) clearances on record.