K250250
- 510(k) number
- K250250
- Device name
- ADVIA Centaur Anti-Thyroid Peroxidase II
- Applicant
- Siemens Healthcare Diagnostics, Inc. NY · US
- Product code
- JZO — System, Test, Thyroid Autoantibody
- Decision date
- 2025-10-17
- Date received
- 2025-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250250.pdf
Official FDA record: K250250
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.