FDA 510(k) Application Details - K110530

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K110530
Device Name	Alkaline Picrate, Colorimetry, 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	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2011
Decision Date	04/30/2012
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