Clearance Summary
IVD-GE02 received FDA 510(k) clearance under submission number K101947, sponsored by Sphere Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2011-03-16.
- Submission: K101947
- Applicant / Sponsor: Sphere Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2011-03-16
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.