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
85 devices
25–48 of 85
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 Jul 13, 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569
Sigma Diagnostics, Inc.
Chemistry · 155d
Cleared Jun 13, 1994
CEDIA DIGOXIN PLUS ASSAY
K941255
Microgenics Corp.
Toxicology · 91d
Cleared Apr 06, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135
Syva Co.
Toxicology · 224d
Cleared Dec 29, 1993
CEDIA DIGOXIN PLUS ASSAY
K934168
Microgenics Corp.
Toxicology · 124d
Cleared Sep 10, 1993
VIDAS DIGOXIN (DIG)
K932250
Biomerieux Vitek, Inc.
General & Plastic Surgery · 123d
Cleared Aug 05, 1993
DIGOXIN TEST SYSTEM, KXT TX
K931123
Syva Co.
Toxicology · 154d
Cleared Jun 07, 1993
ACS DIGOXIN IMMUNOASSAY
K931213
Ciba Corning Diagnostics Corp.
Toxicology · 89d
Cleared Mar 10, 1993
ACA DIGOXIN ANALYTICAL TEST PACK
K930162
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 56d
Cleared Jan 13, 1993
ACCESS DIGOXIN ASSAY
K925802
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared Sep 15, 1992
CEDIA DIGOXIN PLUS ASSAY
K923853
Microgenics Corp.
Toxicology · 50d
Cleared Mar 02, 1992
CEDIA DIGOXIN ASSAY (MODIFICATION)
K920214
Microgenics Corp.
Toxicology · 46d
Cleared Nov 29, 1991
IL TEST(TM DIGOXIN
K914151
Instrumentation Laboratory CO
Immunology · 74d
Cleared May 15, 1991
CEDIA(R) DIGOXIN R' ASSAY
K911941
Microgenics Corp.
Toxicology · 14d
Cleared Mar 21, 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642
Microgenics Corp.
Toxicology · 36d
Cleared Jun 26, 1990
OPUS(TM) DIGOXIN TEST SYSTEM
K901547
Pb Diagnostic Systems, Inc.
Toxicology · 84d
Cleared May 31, 1990
ENZYMUN TEST(R) DIGOXIN
K901216
Boehringer Mannheim Corp.
Toxicology · 78d
Cleared Sep 28, 1989
EZ-BEAD DIGOXIN EIA KIT
K893843
Immunotech Corp.
Toxicology · 126d
Cleared Aug 21, 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910
Syva Co.
Toxicology · 83d
Cleared Mar 08, 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528
Heraeus Kulzer, Inc.
Chemistry · 131d
Cleared Dec 02, 1988
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
K884054
Microgenics Corp.
Chemistry · 67d
Cleared Jul 06, 1988
TDX (R) DIGOXIN NXT
K882233
Abbott Laboratories
Chemistry · 40d
Cleared May 31, 1988
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
K880823
Amersham Corp.
Toxicology · 91d