FDA product code DMJ: Test Reagents For Ethyl Alcohol
DMJ is the FDA product code for test reagents for ethyl alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. Devices under DMJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test Reagents For Ethyl 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 DMJ devices
openFDA lists no recalls for product code DMJ.
Frequently asked questions
What is FDA product code DMJ?
DMJ is the FDA product code for test reagents for ethyl alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is DMJ?
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 DMJ
- Run a recall and safety report across every DMJ manufacturer
- Watch product code DMJ 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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