K240045
- 510(k) number
- K240045
- Device name
- QStat Cartridge
- Applicant
- Hemosonics, LLC NC · US
- Product code
- QFR — Coagulation System For The Measurement Of Whole Bloo
- Decision date
- 2024-03-27
- Date received
- 2024-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240045.pdf
Official FDA record: K240045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.