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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 Primary Antibody
Requester
ventana medical systems
1910 e. innovation park dr.
tucson,  AZ  85755
Contact carol "penny" houston
Regulation Number864.1866
Classification Product Code
PZJ  
Date Received05/30/2017
Decision Date 10/27/2017
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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