KXT · Class II · 21 CFR 862.3320

FDA Product Code KXT: Enzyme Immunoassay, Digoxin

Leading manufacturers include Syva Co., Microgenics Corp. and E.I. Dupont DE Nemours & Co., Inc..

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 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
Cleared Jun 01, 1995
DUPONT ACA DIGOXIN (DGN A) METHOD
K951441
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 64d

About Product Code KXT - Regulatory Context