FDA product code DPJ: Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
DPJ is the FDA product code for radioimmunoassay, amphetamine (125-i), goat antibody, ammonium sulfate sep.. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DPJ. The average 510(k) review took 80 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| 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 DPJ clearance
Top DPJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 2 | 1991-11-01 |
Most recent DPJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913911 | Roche Diagnostic Systems, Inc. | ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET | 1991-11-01 | 63 |
| K912754 | Roche Diagnostic Systems, Inc. | ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE | 1991-09-27 | 98 |
Recalls for DPJ devices
openFDA lists no recalls for product code DPJ.
Frequently asked questions
What is FDA product code DPJ?
DPJ is the FDA product code for radioimmunoassay, amphetamine (125-i), goat antibody, ammonium sulfate sep.. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is DPJ?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPJ?
Across 2 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most DPJ clearances?
Roche Diagnostic Systems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DPJ
- Run a recall and safety report across every DPJ manufacturer
- Watch product code DPJ 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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