510(k) K240800

Access Intrinsic Factor Ab by Beckman Coulter, Inc. — Product Code LIG

K240800 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Intrinsic Factor Ab". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code LIG (Radioassay, Intrinsic Factor Blocking Antibody), a Class II device regulated under 21 CFR 862.1810. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.