FDA Product Code DHX: System, Test, Carcinoembryonic Antigen
Leading manufacturers include Beckman Coulter, Inc. and Ortho-Clinical Diagnostics.
28
Total
28
Cleared
119d
Avg days
1980
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared System, Test, Carcinoembryonic Antigen Devices (Product Code DHX)
28 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
About Product Code DHX - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code DHX since 1980, with 28 receiving FDA clearance (average review time: 119 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
DHX devices are reviewed by the Immunology panel. Browse all Immunology devices →