FDA product code DNX: Lead, Protoporphyrin Zinc Method, Fluorometric
DNX is the FDA product code for lead, protoporphyrin zinc method, fluorometric. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel. Devices under DNX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Lead, Protoporphyrin Zinc Method, Fluorometric |
| Device class | Class II |
| Regulation | 21 CFR 862.3550 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Recalls for DNX devices
openFDA lists no recalls for product code DNX.
Frequently asked questions
What is FDA product code DNX?
DNX is the FDA product code for lead, protoporphyrin zinc method, fluorometric. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel.
What device class is DNX?
Class II, regulation 21 CFR 862.3550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DNX
- Run a recall and safety report across every DNX manufacturer
- Watch product code DNX 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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