510(k) K202573

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus by DiaSorin, Inc. — Product Code LSR

K202573 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus". The FDA issued a decision of Substantially Equivalent on February 18, 2021. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.