510(k) K160650

LIAISON HAV IgM, LIAISON Control HAV IgM by DiaSorin, Inc. — Product Code LOL

K160650 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON HAV IgM, LIAISON Control HAV IgM". The FDA issued a decision of Substantially Equivalent on August 25, 2016. The device falls under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)), a Class II device regulated under 21 CFR 866.3310. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.