510(k) K251543 · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Atellica® IM TSH3-Ultra II (TSH3ULII)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 6, 2026 |
| Received | May 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251543
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.