Source document or public record
FDA 510(k) K251404 — Quantra QStat Cartridge
FDA 510(k) index record K251404. Device: Quantra QStat Cartridge. Applicant as listed: Hemosonics, LLC. Decision date: 2025-08-25.
Source
"device_name": "Quantra QStat Cartridge"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251404.
Device name: Quantra QStat Cartridge. Applicant as listed: Hemosonics, LLC.
Decision date: 2025-08-25. Decision wording: Substantially Equivalent.
Product code: QFR. Regulation: 21 CFR 864.5430. 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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