FDA 510(k) Application Details - K203245

Device Classification Name	System, Test, Tumor Marker, Monitoring, Bladder   More FDA Info for this Device
510(K) Number	K203245
Device Name	System, Test, Tumor Marker, Monitoring, Bladder
Applicant	Nucleix Ltd. 3 Pekeris St. Rehovot 7660203 IL Other 510(k) Applications for this Company
Contact	Shmulik Adler Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2020
Decision Date	05/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review