KXT · Class II · 21 CFR 862.3320

FDA Product Code KXT: Enzyme Immunoassay, Digoxin

Leading manufacturers include Syva Co., Microgenics Corp. and Abbott Laboratories.

85
Total
85
Cleared
86d
Avg days
1979
Since

FDA 510(k) Cleared Enzyme Immunoassay, Digoxin Devices (Product Code KXT)

85 devices
1–24 of 85
Cleared Jul 16, 2021
ADVIA Centaur® Digoxin assay
K193397
Siemens Healthcare Diagnostics, Inc.
Toxicology · 588d
Cleared Apr 08, 2016
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301
Roche Diagnostics
Chemistry · 147d
Cleared Oct 14, 2011
RANDOX DIGOXIN ASSAY
K102346
Randox Laboratories, Ltd.
Chemistry · 421d
Cleared Apr 07, 2010
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K093441
Siemens Healthcare Diagnostics
Chemistry · 153d
Cleared Dec 22, 2008
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
K082953
Biokit, S.A.
Toxicology · 80d
Cleared Jun 02, 2006
AXSYM DIGOXIN III
K061249
Abbott Laboratories
Toxicology · 29d
Cleared Nov 14, 2003
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007
Bayer Diagnostics Corp.
Chemistry · 49d
Cleared Oct 24, 2002
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
K023058
Seradyn
Toxicology · 41d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301
Diagnostic Products Corp.
Toxicology · 61d
Cleared Jul 02, 2001
RANDOX DIGOXIN
K011302
Randox Laboratories, Ltd.
Toxicology · 63d
Cleared Jul 02, 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
K011920
Syva Co., Dade Behring, Inc.
Toxicology · 12d
Cleared Nov 12, 1998
DIGOXIN IMMUNOASSAY
K983323
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Nov 05, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
K983151
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Oct 14, 1998
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
K982935
Beckman Coulter, Inc.
Toxicology · 54d
Cleared Apr 02, 1998
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
K980521
Bayer Corp.
Toxicology · 64d
Cleared Oct 10, 1997
ELECSYS DIGOXIN
K973112
Boehringer Mannheim Corp.
Toxicology · 51d
Cleared Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared May 21, 1997
CEDIA DIGOXIN II
K970883
Boehringer Mannheim Corp.
Toxicology · 72d
Cleared May 14, 1997
CEDIA DIGOXIN
K970881
Boehringer Mannheim Corp.
Toxicology · 65d
Cleared Dec 13, 1996
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
K963062
Beckman Instruments, Inc.
Toxicology · 128d
Cleared Dec 10, 1996
DIGOXIN ENZYME IMMUNOASSAY
K963835
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Sep 25, 1995
AXSYM DIGOXIN II
K953718
Abbott Laboratories
Toxicology · 47d
Cleared Jul 19, 1995
IMX DIGOXIN
K952079
Abbott Laboratories
Toxicology · 77d
Cleared Jun 09, 1995
IL TEST DIGOXIN, PN 181761-00
K951391
Instrumentation Laboratory CO
Toxicology · 74d

About Product Code KXT - Regulatory Context