Clearance Summary
Xprecia Prime Coagulation System received FDA 510(k) clearance under submission number K230802, sponsored by Universal Biosensors Pty, Ltd.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2024-03-15.
- Submission: K230802
- Applicant / Sponsor: Universal Biosensors Pty, Ltd.
- Clearance pathway: Dual Track
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 2024-03-15
Classification & Regulation
This clearance is catalogued under FDA product code GJS and 21 CFR 864.7750, within the Hematology review panel as a Class II device.