K230802
- 510(k) number
- K230802
- Device name
- Xprecia Prime Coagulation System
- Applicant
- Universal Biosensors Pty, Ltd. AU
- Product code
- GJS — Test, Time, Prothrombin
- Decision date
- 2024-03-15
- Date received
- 2023-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K230802.pdf
Official FDA record: K230802
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.