Clearance Summary
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance under submission number K243144, sponsored by Scopio Labs , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2025-06-27.
- Submission: K243144
- Applicant / Sponsor: Scopio Labs , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 2025-06-27
Classification & Regulation
This clearance is catalogued under FDA product code JOY and 21 CFR 864.5260, within the Hematology review panel as a Class II device.