FDA product code DNE: Atomic Absorption, Antimony
DNE is the FDA product code for atomic absorption, antimony. It is a Class I device, regulated under 21 CFR 862.3110 and reviewed by the Clinical Toxicology panel. Devices under DNE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Atomic Absorption, Antimony |
| Device class | Class I |
| Regulation | 21 CFR 862.3110 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DNE devices
openFDA lists no recalls for product code DNE.
Frequently asked questions
What is FDA product code DNE?
DNE is the FDA product code for atomic absorption, antimony. It is a Class I device, regulated under 21 CFR 862.3110 and reviewed by the Clinical Toxicology panel.
What device class is DNE?
Class I, regulation 21 CFR 862.3110. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DNE
- Run a recall and safety report across every DNE manufacturer
- Watch product code DNE 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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