DON · Class II · 21 CFR 862.3320

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

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Bio-Rad and Technicon Instruments Corp..

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 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 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

About Product Code DON - Regulatory Context