Clearance Summary
Sight OLO received FDA 510(k) clearance under submission number K211840, sponsored by S.D. Sight Diagnostics , 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 2022-05-09.
- Submission: K211840
- Applicant / Sponsor: S.D. Sight Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2022-05-09
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.