Clearance Summary
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator received FDA 510(k) clearance under submission number K150412, sponsored by The Binding Site Group , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-08-28.
- Submission: K150412
- Applicant / Sponsor: The Binding Site Group , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5240
- Decision date: 2015-08-28
Classification & Regulation
This clearance is catalogued under FDA product code DAE and 21 CFR 866.5240, within the Immunology review panel as a Class II device.