510(k) K190298

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 by Beckman Coulter Biomedical GmbH — Product Code CDD

K190298 is an FDA 510(k) premarket notification submitted by Beckman Coulter Biomedical GmbH for the device "DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12". The FDA issued a decision of Substantially Equivalent on October 4, 2019. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810.