Clearance Summary
MULTI-ANALYTE DETECTION SYSTEMS received FDA 510(k) clearance under submission number K112810, sponsored by Bio-Rad Laboratories. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2011-10-26.
- Submission: K112810
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 2011-10-26
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.