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KXT — Enzyme Immunoassay, Digoxin Class II

FDA Device Classification

Classification Details

Product Code
KXT
Device Class
Class II
Regulation Number
862.3320
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193397siemens healthcare diagnosticsADVIA Centaur® Digoxin assayJuly 16, 2021
K153301roche diagnosticsElecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIApril 8, 2016
K102346randox laboratoriesRANDOX DIGOXIN ASSAYOctober 14, 2011
K093441siemens healthcare diagnosticsDIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435April 7, 2010
K082953biokitARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-0December 22, 2008
K061249abbott laboratoriesAXSYM DIGOXIN IIIJune 2, 2006
K033007bayer diagnosticsBAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMNovember 14, 2003
K023058seradynQMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEMOctober 24, 2002
K012301diagnostic productsIMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)September 19, 2001
K011302randox laboratoriesRANDOX DIGOXINJuly 2, 2001
K011920syva co., dade behringEMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229July 2, 2001
K983323diagnostic reagentsDIGOXIN IMMUNOASSAYNovember 12, 1998
K983151beckman coulterIMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENTNovember 5, 1998
K982935beckman coulterSYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOROctober 14, 1998
K980521bayerDIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMSApril 2, 1998
K973112boehringer mannheimELECSYS DIGOXINOctober 10, 1997
K972794sigma diagnosticsDIGOXIN DG-II FPIA REAGENT SETJuly 31, 1997
K970883boehringer mannheimCEDIA DIGOXIN IIMay 21, 1997
K970881boehringer mannheimCEDIA DIGOXINMay 14, 1997
K963062beckman instrumentsIMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2December 13, 1996