FDA 510(k) Application Details - K004010

Device Classification Name	Glucose Dehydrogenase, Glucose   More FDA Info for this Device
510(K) Number	K004010
Device Name	Glucose Dehydrogenase, Glucose
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	LUANN OCHS 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	12/26/2000
Decision Date	04/26/2001
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