FDA 510(k) Application Details - K123171

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K123171
Device Name	Azo Dye, Calcium
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	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2012
Decision Date	07/03/2013
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