Clearance Summary
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT received FDA 510(k) clearance under submission number K854483, 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 1985-12-11.
- Submission: K854483
- Applicant / Sponsor: Kallestad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5530
- Decision date: 1985-12-11
Classification & Regulation
This clearance is catalogued under FDA product code KTO and 21 CFR 866.5530, within the Immunology review panel as a Class I device.