510(k) K251995

Access anti-HAV IgM by Beckman Coulter, Inc. — Product Code LOL

K251995 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access anti-HAV IgM". The FDA issued a decision of Substantially Equivalent on January 27, 2026. The device falls under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)), a Class II device regulated under 21 CFR 866.3310. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.