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FDA 510(k) K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

FDA 510(k) index record K222116. Device: Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-07-13.

OtherU.S. Food and Drug Administration (FDA)2023-07-13

Fuente

"device_name": "Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

References

FDA 510(k) public index record K222116.

Device name: Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP). Applicant as listed: Siemens Healthcare Diagnostics, Inc..

Decision date: 2023-07-13. Decision wording: Substantially Equivalent.

Product code: JLW. Regulation: 21 CFR 862.1690. Medical specialty: Clinical Chemistry.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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