Clearance Summary
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) received FDA 510(k) clearance under submission number K081674, sponsored by The Binding Site, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2008-10-15.
- Submission: K081674
- Applicant / Sponsor: The Binding Site, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 2008-10-15
Classification & Regulation
This clearance is catalogued under FDA product code MST and 21 CFR 866.5750, within the Immunology review panel as a Class II device.