510(k) K210272

LIAISON Anti-HAV by DiaSorin, Inc. — Product Code LOL

K210272 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON Anti-HAV". The FDA issued a decision of Substantially Equivalent on February 9, 2021. 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.