Clearance Summary
CEA DESALTING DOLUMN SEPHADEX R received FDA 510(k) clearance under submission number K811394, sponsored by Immuno-Diagnostic Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-06-12.
- Submission: K811394
- Applicant / Sponsor: Immuno-Diagnostic Laboratories
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1981-06-12
Classification & Regulation
This clearance is catalogued under FDA product code DHX and 21 CFR 866.6010, within the Immunology review panel as a Class II device.