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 Primar

Lynch Syndrome Test System

Ventana Medical Systems

The following data is part of a De Novo classification by Ventana Medical Systems with the FDA for 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 Primar.

Pre-market Notification Details

• DeNovo ID: DEN170030
• Device Name: 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 Primar
• Classification: Lynch Syndrome Test System
• Applicant: Ventana Medical Systems 1910 E. Innovation Park Dr. Tucson, AZ 85755
• Contact: Carol "penny" Houston
• Product Code: PZJ
• CFR Regulation Number: 864.1866 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Pathology
• Classification Advisory: Immunology
• Type: Direct
• Date Received: 2017-05-30
• Decision Date: 2017-10-27
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613336100608	DEN170030	000
07613336100592	DEN170030	000
07613336100585	DEN170030	000
07613336100578	DEN170030	000
07613336100561	DEN170030	000