FDA 510(k) Application Details - K110587

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K110587
Device Name	Glucose Dehydrogenase, Glucose
Applicant	BAYER HEALTHCARE, LLC 555 WHITE PLAINS ROAD TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	CHUCK RYAN Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	LFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2011
Decision Date	03/28/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review