FDA 510(k) Application Details - K172471

Device Classification Name	Lambda, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K172471
Device Name	Lambda, Antigen, Antiserum, Control
Applicant	Ventana Medical Systems, Inc. 1910 E Innovation Park Dr Tuscon, AZ 87555 US Other 510(k) Applications for this Company
Contact	Jeffrey Catania Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2017
Decision Date	05/08/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review