Clearance Summary
GLIADIN ANTIBODIES ELISA received FDA 510(k) clearance under submission number K973910, sponsored by Genesis Diagnostics , 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 1999-02-17.
- Submission: K973910
- Applicant / Sponsor: Genesis Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 1999-02-17
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.