FDA product code DPG: Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
DPG is the FDA product code for radioimmunoassay, digitoxin (125-i), rabbit antibody, coated tube sep.. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under DPG, from 3 different applicants. The average 510(k) review took 37 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3300 |
| 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 DPG clearance
Top DPG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pb Diagnostic Systems, Inc. | 1 | 1993-12-22 |
| Diagnostic Products Corp. | 1 | 1981-08-13 |
| Miles Laboratories, Inc. | 1 | 1978-02-28 |
Most recent DPG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935229 | Pb Diagnostic Systems, Inc. | OPUS DIGITOXIN | 1993-12-22 | 51 |
| K812129 | Diagnostic Products Corp. | COAT-A-COUNT DIGITOXIN RIA KIT | 1981-08-13 | 17 |
| K780075 | Miles Laboratories, Inc. | RIALYZE DIGOXIN | 1978-02-28 | 43 |
Recalls for DPG devices
openFDA lists no recalls for product code DPG.
Frequently asked questions
What is FDA product code DPG?
DPG is the FDA product code for radioimmunoassay, digitoxin (125-i), rabbit antibody, coated tube sep.. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel.
What device class is DPG?
Class II, regulation 21 CFR 862.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPG?
Across 3 cleared submissions the average was 37 days from receipt to decision (median 43).
Which companies have the most DPG clearances?
Pb Diagnostic Systems, Inc. (1); Diagnostic Products Corp. (1); Miles Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPG
- Run a recall and safety report across every DPG manufacturer
- Watch product code DPG 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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