FDA 510(k) Application Details - DEN150057

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150057
Device Name	Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
Applicant	ROCHE DIAGNOSTICS 9115 HAGUE ROAD INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	Edie Eads Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2015
Decision Date	12/19/2016
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review