FDA product code DEK: Kappa, Rhodamine, Antigen, Antiserum, Control
DEK is the FDA product code for kappa, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. Devices under DEK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kappa, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DEK devices
openFDA lists no recalls for product code DEK.
Frequently asked questions
What is FDA product code DEK?
DEK is the FDA product code for kappa, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel.
What device class is DEK?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DEK
- Run a recall and safety report across every DEK manufacturer
- Watch product code DEK 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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