FDA product code DIZ: Delayed Analysis, Alcohol
DIZ is the FDA product code for delayed analysis, alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. Devices under DIZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Delayed Analysis, Alcohol |
| Device class | Class II |
| Regulation | 21 CFR 862.3040 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DIZ devices
openFDA lists no recalls for product code DIZ.
Frequently asked questions
What is FDA product code DIZ?
DIZ is the FDA product code for delayed analysis, alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is DIZ?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DIZ
- Run a recall and safety report across every DIZ manufacturer
- Watch product code DIZ 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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