Clearance Summary
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 received FDA 510(k) clearance under submission number K070458, sponsored by Biomedical Diagnostics (Bmd) SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2007-12-21.
- Submission: K070458
- Applicant / Sponsor: Biomedical Diagnostics (Bmd) SA
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2007-12-21
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.