Clearance Summary
VYSIS AUTOVYSION SYSTEM received FDA 510(k) clearance under submission number DEN040010, sponsored by Vysis. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2004-12-13.
- Submission: DEN040010
- Applicant / Sponsor: Vysis
- Clearance pathway: Post-NSE
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.4700
- Decision date: 2004-12-13
Classification & Regulation
This clearance is catalogued under FDA product code NTH and 21 CFR 866.4700, within the Immunology review panel as a Class II device.