FDA 510(k) Application Details - DEN240025

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240025
Device Name	VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
Applicant	Ventana Medical Systems, Inc. 1910 E Innovation Park Drive Tucson, AZ 85755 US Other 510(k) Applications for this Company
Contact	Patricia Wade Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2024
Decision Date	12/05/2024
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review