FDA 510(k) Application Details - K160915

Device Classification Name	More FDA Info for this Device
510(K) Number	K160915
Device Name	Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Applicant	ROCHE DIAGNOSTICS 9115 HAGUE ROAD INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	Adam Clark Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2016
Decision Date	12/14/2016
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