FDA 510(k) Application Details - K190898

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K190898
Device Name	Counter, Differential Cell
Applicant	Sight Diagnostics Ltd. Derech Menachem Begin 23 Tel Aviv IL Other 510(k) Applications for this Company
Contact	Sarah Levy 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	04/05/2019
Decision Date	11/01/2019
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