510(k) K222116 · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 13, 2023 |
| Received | Jul 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica CI Analyzer. Catalog Numbers: 10947347. Open, Classified |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.