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FDA 510(k) K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
FDA 510(k) index record K200256. Device: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2021-07-02.
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"device_name": "ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) 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 K200256.
Device name: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay. Applicant as listed: Siemens Healthcare Diagnostics, Inc..
Decision date: 2021-07-02. Decision wording: Substantially Equivalent.
Product code: PDJ. Regulation: 21 CFR 862.1373. 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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