FDA product code DNH: Resins, Ion-Exchange, Liquid Chromatography
DNH is the FDA product code for resins, ion-exchange, liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DNH. The average 510(k) review took 40 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Resins, Ion-Exchange, Liquid Chromatography |
| Device class | Class I |
| Regulation | 21 CFR 862.2260 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DNH clearance
Top DNH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hamilton Co. | 1 | 1983-08-16 |
Most recent DNH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832199 | Hamilton Co. | HC40/HC75 CATION EXCHANGE RESIN | 1983-08-16 | 40 |
Recalls for DNH devices
openFDA lists no recalls for product code DNH.
Frequently asked questions
What is FDA product code DNH?
DNH is the FDA product code for resins, ion-exchange, liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel.
What device class is DNH?
Class I, regulation 21 CFR 862.2260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DNH?
Across 1 cleared submissions the average was 40 days from receipt to decision (median 40).
Which companies have the most DNH clearances?
Hamilton Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DNH
- Run a recall and safety report across every DNH manufacturer
- Watch product code DNH 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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