FDA product code DNP: Thin Layer Chromatography, Ethosuximide
DNP is the FDA product code for thin layer chromatography, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DNP. The average 510(k) review took 90 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Ethosuximide |
| Device class | Class II |
| Regulation | 21 CFR 862.3380 |
| 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 DNP clearance
Top DNP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pioneering Technologies, Inc. | 1 | 1990-06-20 |
Most recent DNP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901531 | Pioneering Technologies, Inc. | PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE | 1990-06-20 | 90 |
Recalls for DNP devices
openFDA lists no recalls for product code DNP.
Frequently asked questions
What is FDA product code DNP?
DNP is the FDA product code for thin layer chromatography, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel.
What device class is DNP?
Class II, regulation 21 CFR 862.3380. Typical premarket route: 510(k).
How long does a 510(k) take for product code DNP?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most DNP clearances?
Pioneering Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DNP
- Run a recall and safety report across every DNP manufacturer
- Watch product code DNP 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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