FDA product code DPB: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
DPB is the FDA product code for radioimmunoassay, digoxin (125-i), 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 10 510(k) submissions under DPB, from 10 different applicants. The average 510(k) review took 35 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), 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 DPB clearance
Top DPB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 1 | 1985-08-07 |
| Pcl-Ria, Inc. | 1 | 1982-11-01 |
| Cambridge Medical Technology | 1 | 1982-07-02 |
| American Diagnostic Corp. | 1 | 1982-02-23 |
| Radioimmunoassay, Inc. | 1 | 1979-11-13 |
5 more applicants have DPB clearances. See the full list in Caduvo.
Most recent DPB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853021 | Miles Laboratories, Inc. | OPTIMATE DIGOXIN TEST | 1985-08-07 | 20 |
| K823014 | Pcl-Ria, Inc. | DIGOXIN KIT | 1982-11-01 | 19 |
| K821811 | Cambridge Medical Technology | 125I DIGOXIN RADIOIMMUNOASSAY KIT | 1982-07-02 | 14 |
| K820274 | American Diagnostic Corp. | DIGOXIN RADIOIMMUNOASSAY | 1982-02-23 | 21 |
| K792153 | Radioimmunoassay, Inc. | DIGOXIN RADIOIMMUNOASSAY SYSTEM | 1979-11-13 | 18 |
Recalls for DPB devices
openFDA lists no recalls for product code DPB.
Frequently asked questions
What is FDA product code DPB?
DPB is the FDA product code for radioimmunoassay, digoxin (125-i), 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 DPB?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPB?
Across 10 cleared submissions the average was 35 days from receipt to decision (median 20).
Which companies have the most DPB clearances?
Miles Laboratories, Inc. (1); Pcl-Ria, Inc. (1); Cambridge Medical Technology (1); American Diagnostic Corp. (1); Radioimmunoassay, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPB
- Run a recall and safety report across every DPB manufacturer
- Watch product code DPB 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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