FDA 510(k) Application Details - DEN170030

Device Classification Name	More FDA Info for this Device
510(K) 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 a
Applicant	Ventana Medical Systems 1910 E. Innovation Park Dr. Tucson, AZ 85755 US Other 510(k) Applications for this Company
Contact	Carol "Penny" Houston Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2017
Decision Date	10/27/2017
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review