Documento fuente o registro público

FDA 510(k) K200199 — ADVIA Centaur CA 125II

FDA 510(k) index record K200199. Device: ADVIA Centaur CA 125II. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2020-04-06.

OtherU.S. Food and Drug Administration (FDA)2020-04-06

Fuente

"device_name": "ADVIA Centaur CA 125II"

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

FDA 510(k) public index record K200199.

Device name: ADVIA Centaur CA 125II. Applicant as listed: Siemens Healthcare Diagnostics, Inc..

Decision date: 2020-04-06. Decision wording: Substantially Equivalent.

Product code: LTK. Regulation: 21 CFR 866.6010. Medical specialty: Immunology.

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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