FDA 510(k) Application Details - K062239

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K062239
Device Name	Hexokinase, Glucose
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	THERESA AMBROSE BUSH Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	CFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2006
Decision Date	09/11/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review