Clearance Summary
CoaguChek XS Plus System received FDA 510(k) clearance under submission number K253188, sponsored by Roche Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2025-10-24.
- Submission: K253188
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 2025-10-24
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.