Clearance Summary
KERATIN PRIMARY ANTIBODY received FDA 510(k) clearance under submission number K940331, sponsored by Ventana Medical Systems, 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 1996-02-26.
- Submission: K940331
- Applicant / Sponsor: Ventana Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 1996-02-26
Classification & Regulation
This clearance is catalogued under FDA product code DEH and 21 CFR 866.5550, within the Immunology review panel as a Class II device.