Clearance Summary
Image Navigator by Immuno Concepts received FDA 510(k) clearance under submission number K160265, sponsored by Immuno Concepts, N.A. , 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 2016-06-17.
- Submission: K160265
- Applicant / Sponsor: Immuno Concepts, N.A. , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2016-06-17
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.