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