Clearance Summary
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody received FDA 510(k) clearance under submission number DEN170030, sponsored by Ventana Medical Systems. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2017-10-27.
- Submission: DEN170030
- Applicant / Sponsor: Ventana Medical Systems
- Clearance pathway: Direct
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 864.1866
- Decision date: 2017-10-27
Classification & Regulation
This clearance is catalogued under FDA product code PZJ and 21 CFR 864.1866, within the Immunology review panel as a Class II device.