510(k) K181213

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control by Siemens Healthcare Diagnostics, Inc. — Product Code LFZ

K181213 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control". The FDA issued a decision of Substantially Equivalent on July 30, 2018. The device falls under product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.