DNL · Class II · 21 CFR 862.3320

FDA Product Code DNL: Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep.

Leading manufacturers include Clinical Assays, Inc., New England Nuclear and American Diagnostic Corp..

8
Total
8
Cleared
28d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. Devices (Product Code DNL)

8 devices
1–8 of 8
Cleared Jun 25, 1985
TIPSEP DIGOXIN RIA
K852291
Nuclear Diagnostics, Inc.
Toxicology · 27d
Cleared Apr 21, 1981
DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
K810966
E. R. Squibb & Sons, Inc.
Toxicology · 13d
Cleared Dec 18, 1980
DIGOXIN RADIOIMMUNOASSAY KIT
K802841
American Diagnostic Corp.
Toxicology · 36d
Cleared Sep 14, 1978
RIANEN ASSAY SYSTEM, 125I KIT
K781495
New England Nuclear
Immunology · 15d
Cleared Nov 22, 1977
IN VITRO DIGOXIN RIA TEST
K772110
Clinical Assays, Inc.
Immunology · 15d

About Product Code DNL - Regulatory Context