DPO · Class II · 21 CFR 862.3320

FDA Product Code DPO: Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.

Leading manufacturers include Diagnostic Products Corp., Kallestad Laboratories, Inc. and Immuchem Corp..

14
Total
14
Cleared
34d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. Devices (Product Code DPO)

14 devices
1–14 of 14
Cleared Aug 12, 1983
SOPHEIA DIGOXIN EIA KIT
K832163
Diagnostic Products Corp.
Chemistry · 38d
Cleared May 04, 1983
IMMUCHEM COVALENT-COAT RIA KIT
K830962
Immuchem Corp.
Chemistry · 37d
Cleared Jul 23, 1981
COAT-A-COUNT DIGOXIN RIA
K811932
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jul 10, 1981
KALLESTAD QUANTICOAT 125 DIGOXIN
K811776
Kallestad Laboratories, Inc.
Toxicology · 17d
Cleared Mar 19, 1980
RIA PHASE DIGOXIN
K800205
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Aug 16, 1979
AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM
K791325
Micromedic Systems
Toxicology · 35d
Cleared Aug 10, 1979
VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT
K791355
Ventrex Laboratories, Inc.
Toxicology · 20d
Cleared Oct 07, 1977
IGOXIN SOLID PHASE RIA
K771638
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 42d
Cleared Feb 24, 1977
RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO
K770365
Travenol Laboratories, S.A.
Immunology · 1d
Cleared Jan 18, 1977
DIGOXIN CLASP TM RIA KIT
K770069
E. R. Squibb & Sons, Inc.
Toxicology · 5d

About Product Code DPO - Regulatory Context