FDA 510(k) Application Details - K240636

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K240636
Device Name	Counter, Differential Cell
Applicant	PixCell Medical Technologies Hayezira St., South Industrial Zone P.O. Box 1136 Yokneam 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	03/06/2024
Decision Date	05/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review