510(k) K250250

ADVIA Centaur Anti-Thyroid Peroxidase II by Siemens Healthcare Diagnostics, Inc. — Product Code JZO

K250250 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur Anti-Thyroid Peroxidase II". The FDA issued a decision of Substantially Equivalent on October 17, 2025. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.