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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name lynch syndrome test system
De Novo Number 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
Ventana Medical Systems
1910 e. innovation park dr.
tucson,  AZ  85755
Contact carol "penny" houston
Regulation Number864.1866
Classification Product Code
Date Received05/30/2017
Decision Date 10/27/2017
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct