FDA Product Code DHX: System, Test, Carcinoembryonic Antigen
Leading manufacturers include Beckman Coulter, Inc. and Ortho-Clinical Diagnostics.
2
Total
2
Cleared
179d
Avg days
2023
Since
List of System, Test, Carcinoembryonic Antigen devices cleared through 510(k)
2 devices
Cleared
Sep 22, 2023
Access CEA
Beckman Coulter, Inc.
Immunology
267d
Cleared
Aug 23, 2023
VITROS Immunodiagnostic Products CEA Reagent Pack
Ortho-Clinical Diagnostics
Immunology
90d
How to use this database
This page lists all FDA 510(k) submissions for System, Test, Carcinoembryonic Antigen devices (product code DHX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →