FDA 510(k) Application Details - K222148

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K222148
Device Name	Counter, Differential Cell
Applicant	PixCell Medical Technologies, Ltd. 6 Hayezira St. Yoknaem Ilit 2069202 IL Other 510(k) Applications for this Company
Contact	Yaara Ben Yosef 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	07/20/2022
Decision Date	08/16/2023
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