FDA product code DPN: Thin Layer Chromatography, Propoxyphene
DPN is the FDA product code for thin layer chromatography, propoxyphene. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DPN. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Propoxyphene |
| Device class | Class II |
| Regulation | 21 CFR 862.3700 |
| 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 DPN clearance
Top DPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arrow Intl., Inc. | 1 | 2004-04-28 |
Most recent DPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040802 | Arrow Intl., Inc. | HEMOSONIC 200HEMODYNAMIC MONITOR | 2004-04-28 | 30 |
Recalls for DPN devices
openFDA lists no recalls for product code DPN.
Frequently asked questions
What is FDA product code DPN?
DPN is the FDA product code for thin layer chromatography, propoxyphene. It is a Class II device, regulated under 21 CFR 862.3700 and reviewed by the Clinical Toxicology panel.
What device class is DPN?
Class II, regulation 21 CFR 862.3700. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPN?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most DPN clearances?
Arrow Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPN
- Run a recall and safety report across every DPN manufacturer
- Watch product code DPN 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