FDA Product Code LFM: Enzyme Immunoassay, Digitoxin
Leading manufacturers include Diagnostic Products Corp., Abbott Laboratories and Dade Behring, Inc..
20
Total
20
Cleared
73d
Avg days
1983
Since
FDA 510(k) Cleared Enzyme Immunoassay, Digitoxin Devices (Product Code LFM)
20 devices
Cleared
Jul 28, 2006
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
Toxicology
10d
Cleared
Jan 11, 2002
RANDOX DIGITOXIN
Randox Laboratories, Ltd.
Toxicology
189d
Cleared
Mar 31, 1999
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
Dade Behring, Inc.
Toxicology
63d
Cleared
Sep 10, 1996
ABBOTT AXSYM DIGITOXIN (MODIFY)
Abbott Laboratories
Toxicology
46d
Cleared
Dec 29, 1995
AXSYM DIGITOXIN
Abbott Laboratories
Toxicology
99d
Cleared
Jun 09, 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
Bayer Corp.
Chemistry
63d
Cleared
Oct 27, 1994
IMMULITE DIGITOXIN
Diagnostic Products Corp.
Toxicology
113d
Cleared
Oct 20, 1994
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
Eastman Kodak Company
Chemistry
140d
Cleared
Sep 20, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
Syva Co.
Chemistry
117d
Cleared
Jan 27, 1992
DIGITOXIN FPIA REAGENT SET
Sigma Diagnostics, Inc.
Toxicology
56d
Cleared
Mar 09, 1990
MILENIA (TM) DIGITOXIN
Diagnostic Products Corp.
Toxicology
66d
Cleared
Nov 08, 1989
CEDIA DIGITOXIN ASSAY
Microgenics Corp.
Toxicology
23d
Cleared
Apr 26, 1989
ACA(R) DIGITOXIN (DGTX) METHOD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
55d
Cleared
Jun 16, 1986
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
American Dade
Toxicology
17d
Cleared
Aug 16, 1984
TDX DIGITOXIN
Abbott Laboratories
Toxicology
69d
Cleared
Aug 12, 1984
SOPHEIA/MP DIGITOXIN EIA KIT
Diagnostic Products Corp.
Toxicology
40d
Cleared
Jan 28, 1983
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
Diagnostic Products Corp.
Chemistry
21d