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
73–85 of 85
Cleared May 17, 1983
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K831177
American Dade
Immunology · 36d
Cleared Nov 29, 1982
ENZYME-TEST DIGOXIN
K823199
Icl Scientific
Chemistry · 34d
Cleared Aug 12, 1981
ENDAB DIGOXIN KIT
K812054
Immunotech Corp.
Toxicology · 22d
Cleared Oct 10, 1980
OREIA-Q-DIG
K802358
Organon, Inc.
Toxicology · 14d
Cleared Jun 15, 1979
EMIT AUTO DIGOXIN ASSAY
K790937
Syva Co.
Toxicology · 28d
Cleared Apr 10, 1979
OREIA - DIGOXIN
K790521
Organon, Inc.
Toxicology · 25d
Cleared Mar 19, 1979
EMIT AUTO DIGOXIN ASSAY
K790303
Syva Co.
Toxicology · 34d