Quantra QStat Cartridge— 510(k) K251404
Substantially EquivalentHemosonics, LLC
FDA 510(k) clearance K251404 for Quantra QStat Cartridge, Substantially Equivalent on 2025-08-25. Applicant: Hemosonics, LLC.
Clearance details
- Applicant
- Hemosonics, LLC
- Product code
- Code QFR
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.