Clearance Summary
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) received FDA 510(k) clearance under submission number K061613, sponsored by Tripath Imaging. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2007-01-10.
- Submission: K061613
- Applicant / Sponsor: Tripath Imaging
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2007-01-10
Classification & Regulation
This clearance is catalogued under FDA product code NQN and 21 CFR 864.1860, within the Hematology review panel as a Class II device.