FDA 510(k) Application Details - K231517

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K231517
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF35 5PZ GB Other 510(k) Applications for this Company
Contact	Rebecca Lewis Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	DHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2023
Decision Date	08/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review