FDA product code DPD: Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.
DPD is the FDA product code for radioimmunoassay, digoxin (3-h), rabbit antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DPD. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal 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 DPD clearance
Top DPD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medline Industries, Inc. | 1 | 1977-01-06 |
Most recent DPD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K761308 | Medline Industries, Inc. | ELECTRONIC STETHOSCOPE | 1977-01-06 | 14 |
Recalls for DPD devices
openFDA lists no recalls for product code DPD.
Frequently asked questions
What is FDA product code DPD?
DPD is the FDA product code for radioimmunoassay, digoxin (3-h), rabbit antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DPD?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPD?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most DPD clearances?
Medline Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPD
- Run a recall and safety report across every DPD manufacturer
- Watch product code DPD 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.
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