FDA product code DLC: Atomizer, Tlc
DLC is the FDA product code for atomizer, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel. Devices under DLC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Atomizer, Tlc |
| Device class | Class I |
| Regulation | 21 CFR 862.2270 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for DLC devices
openFDA lists no recalls for product code DLC.
Frequently asked questions
What is FDA product code DLC?
DLC is the FDA product code for atomizer, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is DLC?
Class I, regulation 21 CFR 862.2270. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DLC
- Run a recall and safety report across every DLC manufacturer
- Watch product code DLC 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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