Clearance Summary
IMMUNO-CELL IMMUNO-SEP KIT received FDA 510(k) clearance under submission number K812411, sponsored by Kallestad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1981-11-10.
- Submission: K812411
- Applicant / Sponsor: Kallestad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8500
- Decision date: 1981-11-10
Classification & Regulation
This clearance is catalogued under FDA product code JCF and 21 CFR 864.8500, within the Hematology review panel as a Class I device.