Documento fuente o registro público
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.
Fuente
"device_name": "Quantra QStat Cartridge"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-24
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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.