FDA 510(k) Application Details - DEN240035

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240035
Device Name	ConcizuTraceÖ ELISA
Applicant	Randox Laboratories Ltd 55 Diamond Road Crumlin BT29 4QY GB Other 510(k) Applications for this Company
Contact	Karena Shaw Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SES Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	05/22/2025
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review