FDA 510(k) Application Details - K103788

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K103788
Device Name	Hexokinase, Glucose
Applicant	HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE - BP7290 MONTPELLIER 34184 FR Other 510(k) Applications for this Company
Contact	CAROLINE FERRER 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	12/27/2010
Decision Date	11/08/2011
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