FDA 510(k) Application Details - K961311

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K961311
Device Name	Glucose Dehydrogenase, Glucose
Applicant	HEMOCUE, INC. C/O ROBERT JOEL SLOMOF 9229 CRANFORD DRIVE POTOMAC, MD 20854 US Other 510(k) Applications for this Company
Contact	R.J. SLOMOFF 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	04/04/1996
Decision Date	08/23/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review