Source document or public record
FDA 510(k) K200215 — ADVIA Centaur CEA Assay
FDA 510(k) index record K200215. Device: ADVIA Centaur CEA Assay. Applicant as listed: Siemens Healthcare Disgnostics, Inc.. Decision date: 2020-04-13.
Source
"device_name": "ADVIA Centaur CEA Assay"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K200215.
Device name: ADVIA Centaur CEA Assay. Applicant as listed: Siemens Healthcare Disgnostics, Inc..
Decision date: 2020-04-13. Decision wording: Substantially Equivalent.
Product code: DHX. 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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