Panels › Immunology › Product code DHX · Class 2
System, Test, Carcinoembryonic Antigen
Regulation 866.6010
0510(k)s in 12 months (28 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in DHX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2023 | K223921 | Access CEA Beckman Coulter, Inc. | DHX |
| Aug 23, 2023 | K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack Ortho Clinical Diagnostics, GB | DHX |
| Apr 13, 2020 | K200215 | ADVIA Centaur CEA Assay Siemens Healthcare Disgnostics, Inc. | DHX |
| Mar 18, 2009 | K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN Olympus America, Inc., IE | DHX |
| Oct 9, 2008 | K080194 | VIDAS CEA (S) ASSAY bioMerieux, Inc. | DHX |
| Jun 25, 2008 | K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) Dade Behring, Inc. | DHX |
| Jun 17, 2004 | K041322 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | DHX |
| May 6, 2003 | K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. | DHX |
| Dec 18, 2002 | K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY Tosoh Medics, Inc. | DHX |
| Dec 21, 2001 | K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Corp. | DHX |
| Jun 1, 1999 | K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 Beckman | DHX |
| Jun 1, 1999 | K990943 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK Ortho-Clinical Diagnostics, Inc. | DHX |
| May 11, 1999 | K990774 | ABBOTT ARCHITECT CEA Abbott Laboratories | DHX |
| Sep 24, 1998 | K981985 | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 Beckman Coulter, Inc. | DHX |
| Aug 12, 1998 | K981478 | ACS:CENTAUR CEA Chiron Diagnostics Corp. | DHX |
| Jun 29, 1998 | K980887 | ELECSYS CEA ON THE ELECSYS 1010 Boehringer Mannheim Corp. | DHX |
| Apr 21, 1998 | K980855 | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT Dpc Cirrus | DHX |
| Sep 22, 1997 | K970877 | IMMULITE CEA Diagnostic Products Corp. | DHX |
| Mar 18, 1993 | K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | DHX |
| May 21, 1987 | K864877 | TRI-LEVEL LIGAND CONTROL Ciba Corning Diagnostics Corp. | DHX |
| Jan 3, 1984 | K833318 | NORMAL GOAT SERUM Biosan Laboratories, Inc. | DHX |
| Apr 8, 1982 | K820298 | CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV Ventrex Laboratories, Inc. | DHX |
| Sep 29, 1981 | K812658 | CEA CONTROL PLASMA Pacific Hemostasis | DHX |
| Aug 3, 1981 | K810459 | THREE LEVEL CONTROL SERA Bd Becton Dickinson Vacutainer Systems Preanalytic | DHX |
| Jun 12, 1981 | K811394 | CEA DESALTING DOLUMN SEPHADEX R Immuno-Diagnostic Laboratories | DHX |
| Apr 17, 1981 | K810810 | AMICON ULTRAFILTRATION MEMBRANES CMII Amicon, Inc. | DHX |
| Sep 26, 1980 | K801306 | CLINETICS PCA COLUMN Clinetics Corp. | DHX |
| Sep 26, 1980 | K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL Environmental Chemical Specialties | DHX |
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