FDA 510(k) Application Details - K070146

Device Classification Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K070146
Device Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER 34184 FR Other 510(k) Applications for this Company
Contact	PASCAL MACZIOLA Other 510(k) Applications for this Contact
Regulation Number	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2007
Decision Date	10/12/2007
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