FDA product code DMF: Gas Liquid Chromatography, Barbiturate
DMF is the FDA product code for gas liquid chromatography, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel. Devices under DMF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gas Liquid Chromatography, Barbiturate |
| Device class | Class II |
| Regulation | 21 CFR 862.3150 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DMF devices
openFDA lists no recalls for product code DMF.
Frequently asked questions
What is FDA product code DMF?
DMF is the FDA product code for gas liquid chromatography, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel.
What device class is DMF?
Class II, regulation 21 CFR 862.3150. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DMF
- Run a recall and safety report across every DMF manufacturer
- Watch product code DMF 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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