Clearance Summary
BIOPLEX VASCULITIS KIT received FDA 510(k) clearance under submission number K072358, sponsored by Bio-Rad Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2007-10-31.
- Submission: K072358
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2007-10-31
Classification & Regulation
This clearance is catalogued under FDA product code MVJ and 21 CFR 866.5660, within the Immunology review panel as a Class II device.