Source document or public record
FDA 510(k) K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers
FDA 510(k) index record K253212. Device: XR-Series (XR-10, XR-20) Automated Hematology Analyzers. Applicant as listed: Sysmex America, Inc.. Decision date: 2026-05-27.
Source
"device_name": "XR-Series (XR-10, XR-20) Automated Hematology Analyzers"
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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K253212.
Device name: XR-Series (XR-10, XR-20) Automated Hematology Analyzers. Applicant as listed: Sysmex America, Inc..
Decision date: 2026-05-27. Decision wording: Substantially Equivalent.
Product code: GKZ. Regulation: 21 CFR 864.5220. Medical specialty: Hematology.
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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