FDA 510(k) Application Details - K052007

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K052007
Device Name	Hexokinase, Glucose
Applicant	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE MONTPELLIER, HERAULT 34184 FR Other 510(k) Applications for this Company
Contact	TIM LAWTON 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	07/25/2005
Decision Date	12/16/2005
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