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
85 devices
25–48 of 85
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 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 May 03, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K940267
Schiapparelli Biosystems, Inc.
Chemistry · 102d
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 Nov 15, 1993
ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)
K932732
Dupont Medical Products
Toxicology · 161d
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 Dec 17, 1992
DELFIA DIGOXIN KIT
K924594
Wallac OY
Toxicology · 98d
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 Jan 17, 1992
SRI DIGOXIN ENZYME IMMUNOASSAY
K915602
Serono-Baker Diagnostics, Inc.
Toxicology · 35d
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