Clearance Summary
X100 with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance under submission number K201301, 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 2020-10-02.
- Submission: K201301
- Applicant / Sponsor: Scopio Labs , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 2020-10-02
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.