Clearance Summary
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM received FDA 510(k) clearance under submission number K100917, sponsored by Biomedical Diagnostics (Bmd) SA. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2010-11-03.
- Submission: K100917
- Applicant / Sponsor: Biomedical Diagnostics (Bmd) SA
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2010-11-03
Classification & Regulation
This clearance is catalogued under FDA product code MOB and 21 CFR 866.5660, within the Immunology review panel as a Class II device.