Clearance Summary
Virtuoso System for IHC PR (1E2) using iScan HT received FDA 510(k) clearance under submission number K142965, sponsored by Ventana Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2015-07-16.
- Submission: K142965
- Applicant / Sponsor: Ventana Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2015-07-16
Classification & Regulation
This clearance is catalogued under FDA product code OEO and 21 CFR 864.1860, within the Hematology review panel as a Class II device.