FDA 510(k) Application Details - K170353

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K170353
Device Name	Counter, Differential Cell
Applicant	HORIBA ABX SAS Parc Euromedecine Rue du Caducee BP 7290 Montpellier Cedex 4 34184 FR Other 510(k) Applications for this Company
Contact	Caroline Ferrer Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2017
Decision Date	11/01/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review