Clearance Summary
125I-IGE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance under submission number K801019, sponsored by Bio-Ria. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1980-05-20.
- Submission: K801019
- Applicant / Sponsor: Bio-Ria
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1980-05-20
Classification & Regulation
This clearance is catalogued under FDA product code DGC and 21 CFR 866.5510, within the Immunology review panel as a Class II device.