Clearance Summary
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI received FDA 510(k) clearance under submission number K130053, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2013-09-19.
- Submission: K130053
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2013-09-19
Classification & Regulation
This clearance is catalogued under FDA product code MVM and 21 CFR 866.5660, within the Immunology review panel as a Class II device.