DPOClass II

Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.

21 CFR 862.3320 / Clinical Toxicology

DPO is the FDA product code for Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep., a class II device type, regulated under 21 CFR 862.3320. As of 2026-09-10, FDA records hold 14 510(k) clearances under this code, the most recent dated 1991-11-22, and no recalls.

Classification record

Product code: DPO
Device name: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Regulation: 21 CFR 862.3320
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 14
Ingested recalls: 0

Clearances, product code DPO

By decision year

14 clearances under product code DPO with a decision year between 1977 and 1991, 1977 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code DPO by decision year
Year	Clearances
1977	3
1979	2
1980	1
1981	2
1983	2
1984	1
1987	1
1991	2

Applicants with the most clearances

Product code DPO

Applicants holding the most 510(k) clearances under product code DPO
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	2
BD Becton Dickinson Vacutainer Systems Preanalytic	1
Biotope, Inc.	1
Boehringer Mannheim Corp.	1
Canadian Bioclinical, Ltd.	1
Cirrus Diagnostics, Inc.	1
E. R. Squibb & Sons, Inc.	1
Immuchem Corp.	1
Immuno Assay Corp.	1
Kallestad Laboratories, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DPO.