FDA product code DNI: Liquid Chromatography, Amphetamine
DNI is the FDA product code for liquid chromatography, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DNI. The average 510(k) review took 360 days (median 360).
Classification
| Field | Value |
|---|---|
| Device name | Liquid Chromatography, Amphetamine |
| 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 DNI clearance
Top DNI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 1 | 1995-03-27 |
Most recent DNI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941596 | Bio-Rad | REMEDI HS DRUG PROFILING SYSTEM | 1995-03-27 | 360 |
Recalls for DNI devices
openFDA lists no recalls for product code DNI.
Frequently asked questions
What is FDA product code DNI?
DNI is the FDA product code for liquid chromatography, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is DNI?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DNI?
Across 1 cleared submissions the average was 360 days from receipt to decision (median 360).
Which companies have the most DNI clearances?
Bio-Rad (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DNI
- Run a recall and safety report across every DNI manufacturer
- Watch product code DNI 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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