FDA 510(k) Application Details - K232946

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K232946
Device Name	Counter, Differential Cell
Applicant	Horiba ABX Sas Parc Euromedecine, Rue du Caducee BP7290 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	09/20/2023
Decision Date	05/21/2024
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