Clearance Summary
KALLESTAD 125I ANTISERUM TO HUMAN IGE received FDA 510(k) clearance under submission number K812414, sponsored by Kallestad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-09-14.
- Submission: K812414
- Applicant / Sponsor: Kallestad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 1981-09-14
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.