FDA 510(k) Application Details - K232879

Device Classification Name	More FDA Info for this Device
510(K) Number	K232879
Device Name	Roche Digital Pathology Dx (VENTANA DP 200)
Applicant	Ventana Medical Systems, Inc. (Ventana, VMSI, Roche Tissue Diagnostics, RTD) 1910 E. Innovation Park Drive Tucson, AZ 85755 US Other 510(k) Applications for this Company
Contact	Cameron Smith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2023
Decision Date	06/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review