FDA 510(k) Application Details - K042767

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K042767
Device Name	Hexokinase, Glucose
Applicant	THERMO ELECTRON CORPORATION 331 SOUTH 104TH STREET LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	BOLA NICHOLSON 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	10/05/2004
Decision Date	04/27/2005
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