Clearance Summary
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY received FDA 510(k) clearance under submission number K103818, sponsored by Ventana Medical Sytems, 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 2011-11-16.
- Submission: K103818
- Applicant / Sponsor: Ventana Medical Sytems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2011-11-16
Classification & Regulation
This clearance is catalogued under FDA product code MXZ and 21 CFR 864.1860, within the Hematology review panel as a Class II device.