FDA product code DPE: Thin Layer Chromatography, Diphenylhydantoin
DPE is the FDA product code for thin layer chromatography, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DPE. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Diphenylhydantoin |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| 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 DPE clearance
Top DPE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technicon Instruments Corp. | 1 | 1979-11-13 |
Most recent DPE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791979 | Technicon Instruments Corp. | TECHNICON FAST-LC SYS. ANTICONVU DRUGS | 1979-11-13 | 49 |
Recalls for DPE devices
openFDA lists no recalls for product code DPE.
Frequently asked questions
What is FDA product code DPE?
DPE is the FDA product code for thin layer chromatography, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is DPE?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPE?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most DPE clearances?
Technicon Instruments Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPE
- Run a recall and safety report across every DPE manufacturer
- Watch product code DPE 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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