Clearance Summary
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM received FDA 510(k) clearance under submission number K081217, sponsored by Hycor Biomedical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2008-05-22.
- Submission: K081217
- Applicant / Sponsor: Hycor Biomedical, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 2008-05-22
Classification & Regulation
This clearance is catalogued under FDA product code DHB and 21 CFR 866.5750, within the Immunology review panel as a Class II device.