Clearance Summary
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 received FDA 510(k) clearance under submission number K041658, 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 2004-12-20.
- Submission: K041658
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2004-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LKJ and 21 CFR 866.5100, within the Immunology review panel as a Class II device.