Source document or public record
FDA 510(k) K260214 — STA® - Liquid Anti-Xa
FDA 510(k) index record K260214. Device: STA® - Liquid Anti-Xa. Applicant as listed: Diagnostica Stago, Inc.. Decision date: 2026-09-24.
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"device_name": "STA® - Liquid Anti-Xa"
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 K260214.
Device name: STA® - Liquid Anti-Xa. Applicant as listed: Diagnostica Stago, Inc..
Decision date: 2026-09-24. Decision wording: Substantially Equivalent.
Product code: KFF. Regulation: 21 CFR 864.7525. 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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