Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more— 510(k) K243570
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K243570 for Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more, Substantially Equivalent on 2025-04-25. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Device name as filed
- Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Adverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.