Clearance Summary
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS received FDA 510(k) clearance under submission number K103834, 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 2012-03-30.
- Submission: K103834
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2012-03-30
Classification & Regulation
This clearance is catalogued under FDA product code MID and 21 CFR 866.5660, within the Immunology review panel as a Class II device.