KXT · Class II · 21 CFR 862.3320

FDA Product Code KXT: Enzyme Immunoassay, Digoxin

Leading manufacturers include Syva Co., Abbott Laboratories and E.I. Dupont DE Nemours & Co., Inc..

85
Total
85
Cleared
86d
Avg days
1979
Since
Stable submission activity - 0 submissions in the last 2 years

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 Jun 02, 2006
AXSYM DIGOXIN III
K061249
Abbott Laboratories
Toxicology · 29d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301
Diagnostic Products Corp.
Toxicology · 61d
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 Oct 10, 1997
ELECSYS DIGOXIN
K973112
Boehringer Mannheim Corp.
Toxicology · 51d
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 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
Cleared Jun 01, 1995
EMIT 2000 DIGOXIN ASSAY
K951755
Syva Co.
Chemistry · 45d
Cleared Apr 10, 1995
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
K943983
Instrumentation Laboratory CO
Toxicology · 307d
Cleared Feb 22, 1995
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 68d
Cleared Dec 19, 1994
AXSYM DIGOXIN
K944506
Abbott Laboratories
Microbiology · 96d
Cleared Nov 15, 1994
EMIT 2000 DIGOXIN ASSAY
K943500
Syva Co.
Toxicology · 133d
Cleared Apr 06, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135
Syva Co.
Toxicology · 224d
Cleared Aug 05, 1993
DIGOXIN TEST SYSTEM, KXT TX
K931123
Syva Co.
Toxicology · 154d
Cleared Mar 10, 1993
ACA DIGOXIN ANALYTICAL TEST PACK
K930162
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 56d
Cleared Nov 29, 1991
IL TEST(TM DIGOXIN
K914151
Instrumentation Laboratory CO
Immunology · 74d
Cleared May 31, 1990
ENZYMUN TEST(R) DIGOXIN
K901216
Boehringer Mannheim Corp.
Toxicology · 78d
Cleared Aug 21, 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910
Syva Co.
Toxicology · 83d

About Product Code KXT - Regulatory Context

510(k) Submission Activity

85 total 510(k) submissions under product code KXT since 1979, with 85 receiving FDA clearance (average review time: 86 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.