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