FDA product code DIN: Gas Chromatography, Cocaine
DIN is the FDA product code for gas chromatography, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. Devices under DIN reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Cocaine |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DIN devices
openFDA lists no recalls for product code DIN.
Frequently asked questions
What is FDA product code DIN?
DIN is the FDA product code for gas chromatography, cocaine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is DIN?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DIN
- Run a recall and safety report across every DIN manufacturer
- Watch product code DIN 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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