FDA 510(k) Application Details - K181492

Device Classification Name	System, Test, Immunological, Antigen, Tumor   More FDA Info for this Device
510(K) Number	K181492
Device Name	System, Test, Immunological, Antigen, Tumor
Applicant	Roche Diagnostics 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Adennis Cora Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2018
Decision Date	06/22/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review