Clearance Summary
CORNING IMMUNOFIXATION SYS received FDA 510(k) clearance under submission number K843614, sponsored by Corning Medical & Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1984-10-05.
- Submission: K843614
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1984-10-05
Classification & Regulation
This clearance is catalogued under FDA product code CZP and 21 CFR 866.5510, within the Immunology review panel as a Class II device.