510(k) K243570 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Nov 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243570
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.