DOG · Class II · 21 CFR 862.3320

FDA Product Code DOG: Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol

Leading manufacturers include Dade, Baxter Travenol Diagnostics, Inc., Syva Co. and American Dade.

5
Total
5
Cleared
21d
Avg days
1976
Since

FDA 510(k) Cleared Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol Devices (Product Code DOG)

5 devices
1–5 of 5
Cleared Dec 22, 1980
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.
K803045
American Dade
Toxicology · 21d
Cleared Oct 21, 1976
EMIT DIGOKIN ASSAY
K760709
Syva Co.
Toxicology · 27d
Cleared Aug 23, 1976
DATA-TOPE SYSTEM DIGOXIN RIA
K760416
Dade, Baxter Travenol Diagnostics, Inc.
Toxicology · 14d

About Product Code DOG - Regulatory Context