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