K251404
- 510(k) number
- K251404
- Device name
- Quantra QStat Cartridge
- Applicant
- Hemosonics, LLC NC · US
- Product code
- QFR — Coagulation System For The Measurement Of Whole Bloo
- Decision date
- 2025-08-25
- Date received
- 2025-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
510(k) Summary (official FDA PDF): K251404.pdf
Official FDA record: K251404
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.