510(k) K243570
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) by
Siemens Healthcare Diagnostics
— Product Code JLW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2025
- Date Received
- November 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Device Class
- Class II
- Regulation Number
- 862.1690
- Review Panel
- CH
- Submission Type