FDA 510(k) Application Details - K032076

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K032076
Device Name	Glucose Dehydrogenase, Glucose
Applicant	CHDIAGNOSTICS LLC 1801 ROCKVILLE PIKE SUITE 300 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	RICHARD N PHILLIPS 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	07/07/2003
Decision Date	09/30/2003
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