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DHX — System, Test, Carcinoembryonic Antigen Class II

FDA Device Classification

Classification Details

Product Code
DHX
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223921beckman coulterAccess CEASeptember 22, 2023
K231517ortho clinical diagnosticsVITROS Immunodiagnostic Products CEA Reagent PackAugust 23, 2023
K200215siemens healthcare disgnosticsADVIA Centaur CEA AssayApril 13, 2020
K081615olympus americaOLYMPUS CEA - CARCINOEMBRYONIC ANTIGENMarch 18, 2009
K080194biomerieuxVIDAS CEA (S) ASSAYOctober 9, 2008
K071603dade behringDIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)June 25, 2008
K041322ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERSJune 17, 2004
K031270beckman coulterACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMSMay 6, 2003
K023893tosoh medicsST AIA-PACK CEA ENZYME IMMUNOASSAYDecember 18, 2002
K013568bayerCEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMDecember 21, 2001
K990943ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCJune 1, 1999
K991707beckmanMODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, June 1, 1999
K990774abbott laboratoriesABBOTT ARCHITECT CEAMay 11, 1999
K981985beckman coulterACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206September 24, 1998
K981478chiron diagnosticsACS:CENTAUR CEAAugust 12, 1998
K980887boehringer mannheimELECSYS CEA ON THE ELECSYS 1010June 29, 1998
K980855dpc cirrusIMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KITApril 21, 1998
K970877diagnostic productsIMMULITE CEASeptember 22, 1997
K924857tosoh medicsAIA-PACK CEA CALIBRATION VERIFICATION TEST SETMarch 18, 1993
K864877ciba corning diagnosticsTRI-LEVEL LIGAND CONTROLMay 21, 1987