K233050
- 510(k) number
- K233050
- Device name
- ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- Applicant
- Siemens Healthcare Diagnostics, Inc. NY · US
- Product code
- JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
- Decision date
- 2024-04-04
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K233050.pdf
Official FDA record: K233050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.