510(k) K140496

Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents by Beckman Coulter, Inc. — Product Code CDD

K140496 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents". The FDA issued a decision of Substantially Equivalent on September 16, 2014. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.