FDA product code DMS: Gases, Glc
DMS is the FDA product code for gases, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel. Devices under DMS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gases, Glc |
| Device class | Class I |
| Regulation | 21 CFR 862.2250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for DMS devices
openFDA lists no recalls for product code DMS.
Frequently asked questions
What is FDA product code DMS?
DMS is the FDA product code for gases, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel.
What device class is DMS?
Class I, regulation 21 CFR 862.2250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DMS
- Run a recall and safety report across every DMS manufacturer
- Watch product code DMS 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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