Atlas FDA

DHX

28 FDA 510(k) clearances · Product code

99 daysmedian time to decision
282 days90th percentile
28clearances measured

FDA profile

Official device name
System, Test, Carcinoembryonic Antigen
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 22 · 2018: 20 · 2019: 12 · 2020: 14 · 2023: 15 · 2025: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access CEA (K223921)Beckman Coulter, Inc.2023-09-22
VITROS Immunodiagnostic Products CEA Reagent Pack (K231517)Ortho Clinical Diagnostics2023-08-23
ADVIA Centaur CEA Assay (K200215)Siemens Healthcare Disgnostics, Inc.2020-04-13
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (K081615)Olympus America, Inc.2009-03-18
VIDAS CEA (S) ASSAY (K080194)bioMerieux, Inc.2008-10-09
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (K071603)Dade Behring, Inc.2008-06-25
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (K041322)Ortho-Clinical Diagnostics, Inc.2004-06-17
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (K031270)Beckman Coulter, Inc.2003-05-06
ST AIA-PACK CEA ENZYME IMMUNOASSAY (K023893)Tosoh Medics, Inc.2002-12-18
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K013568)Bayer Corp.2001-12-21
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 (K991707)Beckman1999-06-01
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK (K990943)Ortho-Clinical Diagnostics, Inc.1999-06-01
ABBOTT ARCHITECT CEA (K990774)Abbott Laboratories1999-05-11
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 (K981985)Beckman Coulter, Inc.1998-09-24
ACS:CENTAUR CEA (K981478)Chiron Diagnostics Corp.1998-08-12
ELECSYS CEA ON THE ELECSYS 1010 (K980887)Boehringer Mannheim Corp.1998-06-29
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT (K980855)Dpc Cirrus1998-04-21
IMMULITE CEA (K970877)Diagnostic Products Corp.1997-09-22
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET (K924857)Tosoh Medics, Inc.1993-03-18
TRI-LEVEL LIGAND CONTROL (K864877)Ciba Corning Diagnostics Corp.1987-05-21
NORMAL GOAT SERUM (K833318)Biosan Laboratories, Inc.1984-01-03
CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV (K820298)Ventrex Laboratories, Inc.1982-04-08
CEA CONTROL PLASMA (K812658)Pacific Hemostasis1981-09-29
THREE LEVEL CONTROL SERA (K810459)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-08-03
CEA DESALTING DOLUMN SEPHADEX R (K811394)Immuno-Diagnostic Laboratories1981-06-12
AMICON ULTRAFILTRATION MEMBRANES CMII (K810810)Amicon, Inc.1981-04-17
CLINETICS PCA COLUMN (K801306)Clinetics Corp.1980-09-26
CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (K792377)Environmental Chemical Specialties1980-09-26

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Every clearance here is in the API, with alerts when new ones post.