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