K251543
- 510(k) number
- K251543
- Device name
- Atellica® IM TSH3-Ultra II (TSH3ULII)
- Applicant
- Siemens Healthcare Diagnostics, Inc. NY · US
- Product code
- JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
- Decision date
- 2026-02-06
- Date received
- 2025-05-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251543.pdf
Official FDA record: K251543
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.