FDA 510(k) Applications for Medical Device Product Code "KXT"
(Enzyme Immunoassay, Digoxin)

FDA 510(k) Number Applicant Device Name Decision Date
K061249 ABBOTT LABORATORIES AXSYM DIGOXIN III 06/02/2006
K980521 BAYER CORP. DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS 04/02/1998
K033007 BAYER DIAGNOSTICS CORP. BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM 11/14/2003
K983151 BECKMAN COULTER, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT 11/05/1998
K982935 BECKMAN COULTER, INC. SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR 10/14/1998
K963062 BECKMAN INSTRUMENTS, INC. IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 12/13/1996
K082953 BIOKIT S.A. ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 12/22/2008
K970881 BOEHRINGER MANNHEIM CORP. CEDIA DIGOXIN 05/14/1997
K970883 BOEHRINGER MANNHEIM CORP. CEDIA DIGOXIN II 05/21/1997
K973112 BOEHRINGER MANNHEIM CORP. ELECSYS DIGOXIN 10/10/1997
K012301 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) 09/19/2001
K963835 DIAGNOSTIC REAGENTS, INC. DIGOXIN ENZYME IMMUNOASSAY 12/10/1996
K983323 DIAGNOSTIC REAGENTS, INC. DIGOXIN IMMUNOASSAY 11/12/1998
K011302 RANDOX LABORATORIES, LTD. RANDOX DIGOXIN 07/02/2001
K102346 RANDOX LABORATORIES, LTD. RANDOX DIGOXIN ASSAY 10/14/2011
K153301 ROCHE DIAGNOSTICS Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II 04/08/2016
K023058 SERADYN QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM 10/24/2002
K093441 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 04/07/2010
K193397 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur« Digoxin assay 07/16/2021
K972794 SIGMA DIAGNOSTICS, INC. DIGOXIN DG-II FPIA REAGENT SET 07/31/1997
K011920 SYVA CO., DADE BEHRING, INC. EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 07/02/2001


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