DON · Class II · 21 CFR 862.3320

FDA Product Code DON: Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.

Leading manufacturers include Ciba Corning Diagnostics Corp., Burroughs Wellcome Co. and Mallinckrodt Critical Care.

17
Total
17
Cleared
37d
Avg days
1976
Since

FDA 510(k) Cleared Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. Devices (Product Code DON)

17 devices
1–17 of 17
Cleared Sep 10, 1990
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
K902861
Ciba Corning Diagnostics Corp.
Chemistry · 74d
Cleared Jul 08, 1988
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
K881679
Ciba Corning Diagnostics Corp.
Chemistry · 80d
Cleared Mar 23, 1984
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
K840461
Corning Medical & Scientific
Toxicology · 50d
Cleared Apr 26, 1982
ENZYMUNE-TEST DIGOXIN
K821000
Icl Scientific
Chemistry · 18d
Cleared Dec 22, 1980
DIGOXIN RIABEAD DIAGNOSTIC KIT
K803075
Abbott Laboratories
Toxicology · 17d
Cleared Sep 27, 1979
TECHNICON STAR SYSTEM
K791549
Technicon Instruments Corp.
Toxicology · 45d
Cleared Oct 24, 1978
RIA, DIGOXIN
K781660
E. R. Squibb & Sons, Inc.
Toxicology · 26d
Cleared Apr 24, 1978
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
K780475
Burroughs Wellcome Co.
Toxicology · 31d
Cleared Feb 13, 1978
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA
K772422
Bio-Rad
Immunology · 47d
Cleared Dec 20, 1977
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS
K772098
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 43d
Cleared Aug 25, 1977
CEBTRIA DIGOXIN RIA
K771255
Union Carbide Corp.
Toxicology · 44d
Cleared Mar 16, 1977
CAMMADISK DIGOXIN
K770269
Burroughs Wellcome Co.
Toxicology · 33d
Cleared Nov 01, 1976
SPAC DIGOXIN KIT
K760800
Mallinckrodt Critical Care
Toxicology · 24d

About Product Code DON - Regulatory Context