FDA product code DMK: Lead, Protoporphyrin, Fluorometric
DMK is the FDA product code for lead, protoporphyrin, fluorometric. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel. Devices under DMK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Lead, Protoporphyrin, 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 DMK devices
openFDA lists no recalls for product code DMK.
Frequently asked questions
What is FDA product code DMK?
DMK is the FDA product code for lead, protoporphyrin, fluorometric. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel.
What device class is DMK?
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 DMK
- Run a recall and safety report across every DMK manufacturer
- Watch product code DMK 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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