DHX · Class II · 21 CFR 866.6010

FDA Product Code DHX: System, Test, Carcinoembryonic Antigen

Leading manufacturers include Beckman Coulter, Inc., Dade Behring, Inc. and bioMerieux, Inc..

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
1–24 of 28
Cleared Sep 22, 2023
Access CEA
K223921
Beckman Coulter, Inc.
Immunology · 267d
Cleared Aug 23, 2023
VITROS Immunodiagnostic Products CEA Reagent Pack
K231517
Ortho-Clinical Diagnostics
Immunology · 90d
Cleared Apr 13, 2020
ADVIA Centaur CEA Assay
K200215
Siemens Healthcare Disgnostics, Inc.
Immunology · 76d
Cleared Oct 09, 2008
VIDAS CEA (S) ASSAY
K080194
bioMerieux, Inc.
Immunology · 258d
Cleared Jun 25, 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603
Dade Behring, Inc.
Immunology · 379d
Cleared May 06, 2003
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
K031270
Beckman Coulter, Inc.
Immunology · 15d
Cleared May 11, 1999
ABBOTT ARCHITECT CEA
K990774
Abbott Laboratories
Immunology · 63d
Cleared Sep 24, 1998
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
K981985
Beckman Coulter, Inc.
Immunology · 111d
Cleared Jun 29, 1998
ELECSYS CEA ON THE ELECSYS 1010
K980887
Boehringer Mannheim Corp.
Immunology · 112d
Cleared Sep 22, 1997
IMMULITE CEA
K970877
Diagnostic Products Corp.
Immunology · 196d
Cleared Aug 03, 1981
THREE LEVEL CONTROL SERA
K810459
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 164d

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.