FDA product code DLO: Indicator, Silica Gel Fluorescent, Tlc
DLO is the FDA product code for indicator, silica gel fluorescent, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel. Devices under DLO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Indicator, Silica Gel Fluorescent, Tlc |
| Device class | Class I |
| Regulation | 21 CFR 862.2270 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for DLO devices
openFDA lists no recalls for product code DLO.
Frequently asked questions
What is FDA product code DLO?
DLO is the FDA product code for indicator, silica gel fluorescent, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is DLO?
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 DLO
- Run a recall and safety report across every DLO manufacturer
- Watch product code DLO 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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