Clearance Summary
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM received FDA 510(k) clearance under submission number K093954, 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 2010-08-24.
- Submission: K093954
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 2010-08-24
Classification & Regulation
This clearance is catalogued under FDA product code NHX and 21 CFR 866.5775, within the Immunology review panel as a Class II device.