FDA product code DIM: Gas Chromatography, Salicylate
DIM is the FDA product code for gas chromatography, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel. Devices under DIM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Salicylate |
| Device class | Class II |
| Regulation | 21 CFR 862.3830 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DIM devices
openFDA lists no recalls for product code DIM.
Frequently asked questions
What is FDA product code DIM?
DIM is the FDA product code for gas chromatography, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel.
What device class is DIM?
Class II, regulation 21 CFR 862.3830. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DIM
- Run a recall and safety report across every DIM manufacturer
- Watch product code DIM 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times