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