FDA 510(k) Application Details - K243144

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K243144
Device Name	Device, Automated Cell-Locating
Applicant	Scopio Labs Ltd. 10 Hasharon Street Tel Aviv 6618502 IL Other 510(k) Applications for this Company
Contact	Ifat Raved Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	JOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	06/27/2025
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