FDA 510(k) Application Details - K133676

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K133676
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE MONTPELLIER 34184 FR Other 510(k) Applications for this Company
Contact	CAROLINE FERRER Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2013
Decision Date	07/11/2014
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