Clearance Summary
SCANVIEW HER2/NEU FISH SYSTEM received FDA 510(k) clearance under submission number K101291, sponsored by Applied Spectral Imaging , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2010-11-23.
- Submission: K101291
- Applicant / Sponsor: Applied Spectral Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.4700
- Decision date: 2010-11-23
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.