LFM · Class II · 21 CFR 862.3300

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
1–20 of 20
Cleared Jul 28, 2006
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
K062024
Dade Behring, Inc.
Toxicology · 10d
Cleared Mar 31, 1999
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251
Dade Behring, Inc.
Toxicology · 63d
Cleared Sep 10, 1996
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158
Abbott Laboratories
Toxicology · 46d
Cleared Dec 29, 1995
AXSYM DIGITOXIN
K954420
Abbott Laboratories
Toxicology · 99d
Cleared Oct 27, 1994
IMMULITE DIGITOXIN
K943235
Diagnostic Products Corp.
Toxicology · 113d
Cleared Oct 20, 1994
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
K942610
Eastman Kodak Company
Chemistry · 140d
Cleared Sep 20, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619
Syva Co.
Chemistry · 117d
Cleared Mar 09, 1990
MILENIA (TM) DIGITOXIN
K900013
Diagnostic Products Corp.
Toxicology · 66d
Cleared Apr 26, 1989
ACA(R) DIGITOXIN (DGTX) METHOD
K891094
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Aug 16, 1984
TDX DIGITOXIN
K842280
Abbott Laboratories
Toxicology · 69d
Cleared Aug 12, 1984
SOPHEIA/MP DIGITOXIN EIA KIT
K842578
Diagnostic Products Corp.
Toxicology · 40d
Cleared Jan 28, 1983
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
K830035
Diagnostic Products Corp.
Chemistry · 21d

About Product Code LFM - Regulatory Context