LCS · Class II · 21 CFR 862.3320

FDA Product Code LCS: Radioimmunoassay, Digoxin (125-i)

Leading manufacturers include Pharmacia, Inc., Sorin Biomedica, Fiat, USA, Inc. and E. R. Squibb & Sons, Inc..

15
Total
15
Cleared
39d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Digoxin (125-i) Devices (Product Code LCS)

15 devices
1–15 of 15
Cleared Aug 24, 1992
DIGOXIN COATED TUBE RIA
K922353
Monobind
Toxicology · 97d
Cleared Aug 30, 1991
QMS - DIGOXIN
K913562
Seradyn, Inc.
Chemistry · 21d
Cleared Oct 30, 1989
INNOFLUOR DIGOXIN REAGENT SET
K895828
Innotron of Oregon, Inc.
Toxicology · 28d
Cleared Jan 17, 1989
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884707
Cyberfluor, Inc.
Chemistry · 69d
Cleared Feb 19, 1988
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748
Sclavo, Inc.
Toxicology · 93d
Cleared Feb 12, 1987
DART DIGOXIN ASSAY
K864802
Coulter Electronics, Inc.
Chemistry · 65d
Cleared Feb 05, 1982
TDX DIGOXIN
K820154
Abbott Laboratories
Toxicology · 17d
Cleared Dec 22, 1980
I-125 LABELED DIGOXIN
K803047
Pcl-Ria, Inc.
Toxicology · 21d
Cleared Jul 08, 1980
AMERLEX DIGOXIN RIA KIT
K801413
Amersham Corp.
Toxicology · 22d
Cleared May 08, 1980
DIGOXIN CLASP RIA KIT
K800997
E. R. Squibb & Sons, Inc.
Toxicology · 13d
Cleared Apr 24, 1980
DIGOCTK 125
K800773
Sorin Biomedica, Fiat, USA, Inc.
Toxicology · 17d
Cleared Apr 05, 1977
PHALDEBAS DIGOXIN RIA
K770322
Pharmacia, Inc.
Toxicology · 47d

About Product Code LCS - Regulatory Context