FDA product code DLY: Plate, Alumina, Tlc
DLY is the FDA product code for plate, alumina, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel. Devices under DLY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Plate, Alumina, 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 DLY devices
openFDA lists no recalls for product code DLY.
Frequently asked questions
What is FDA product code DLY?
DLY is the FDA product code for plate, alumina, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is DLY?
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 DLY
- Run a recall and safety report across every DLY manufacturer
- Watch product code DLY 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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