FDA product code DPO: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
DPO is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, coated tube sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 14 510(k) submissions under DPO, from 13 different applicants. The average 510(k) review took 34 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DPO clearance
Top DPO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 2 | 1983-08-12 |
| Cirrus Diagnostics, Inc. | 1 | 1991-11-22 |
| Biotope, Inc. | 1 | 1991-01-17 |
| Canadian Bioclinical, Ltd. | 1 | 1987-02-02 |
| Immuno Assay Corp. | 1 | 1984-01-17 |
8 more applicants have DPO clearances. See the full list in Caduvo.
Most recent DPO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914833 | Cirrus Diagnostics, Inc. | IMMULITE DIGOXIN | 1991-11-22 | 28 |
| K905719 | Biotope, Inc. | ECLIPSE ICA DIGOXIN | 1991-01-17 | 27 |
| K864449 | Canadian Bioclinical, Ltd. | DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | 1987-02-02 | 82 |
| K833842 | Immuno Assay Corp. | RIA COAT DIGOXIN | 1984-01-17 | 75 |
| K832163 | Diagnostic Products Corp. | SOPHEIA DIGOXIN EIA KIT | 1983-08-12 | 38 |
Recalls for DPO devices
openFDA lists no recalls for product code DPO.
Frequently asked questions
What is FDA product code DPO?
DPO is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, coated tube sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DPO?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPO?
Across 14 cleared submissions the average was 34 days from receipt to decision (median 32).
Which companies have the most DPO clearances?
Diagnostic Products Corp. (2); Cirrus Diagnostics, Inc. (1); Biotope, Inc. (1); Canadian Bioclinical, Ltd. (1); Immuno Assay Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPO
- Run a recall and safety report across every DPO manufacturer
- Watch product code DPO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times