K250816
- 510(k) number
- K250816
- Device name
- ADVIA Centaur Anti-Thyroglobulin II (aTgII)
- Applicant
- Siemens Healthcare Diagnostics, Inc. NJ · US
- Product code
- JNL — Immunochemical, Thyroglobulin Autoantibody
- Decision date
- 2025-12-04
- Date received
- 2025-03-18
- 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: K250816.pdf
Official FDA record: K250816
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.