FDA 510(k) Application Details - K212176

Device Classification Name	More FDA Info for this Device
510(K) Number	K212176
Device Name	CINtec Histology
Applicant	Ventana Medical Systems, Inc. 1910 E Innovation Park Drive Tucson, AZ 85755 US Other 510(k) Applications for this Company
Contact	Stacci Cronk Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2021
Decision Date	12/10/2021
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