FDA 510(k) Application Details - K110137

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K110137
Device Name	Enzymatic Method, Creatinine
Applicant	HORIBA ABX S.A.S. PARC EUROMEDECINE RUE DU CADUCEE-BP 7290 MONTPELLIER CEDEX 4, HERAULT 34184 FR Other 510(k) Applications for this Company
Contact	CAROLINE FERRER Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	JFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2011
Decision Date	08/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review