FDA 510(k) Application Details - K113307

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K113307
Device Name	Glucose Dehydrogenase, Glucose
Applicant	HMD BIOMEDICAL, INC. No 181 Minsheng St, Xinpu Township Hsinchu County 305 TW Other 510(k) Applications for this Company
Contact	JESSICA TUNG 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	11/08/2011
Decision Date	07/27/2012
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