K243570
- 510(k) number
- K243570
- Device name
- Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
- Applicant
- Siemens Healthcare Diagnostics DE · US
- Product code
- JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
- Decision date
- 2025-04-25
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243570.pdf
Official FDA record: K243570
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.