Clearance Summary
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System received FDA 510(k) clearance under submission number K203599, 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 2023-05-26.
- Submission: K203599
- 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: 2023-05-26
Classification & Regulation
This clearance is catalogued under FDA product code KTL and 21 CFR 866.5100, within the Immunology review panel as a Class II device.