Clearance Summary
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) received FDA 510(k) clearance under submission number K063498, sponsored by Sebia. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2007-06-11.
- Submission: K063498
- Applicant / Sponsor: Sebia
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5130
- Decision date: 2007-06-11
Classification & Regulation
This clearance is catalogued under FDA product code OBZ and 21 CFR 866.5130, within the Immunology review panel as a Class II device.