FDA product code DDK: Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control
DDK is the FDA product code for beta-2-glycoprotein iii, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5440 and reviewed by the Immunology panel. Devices under DDK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5440 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DDK devices
openFDA lists no recalls for product code DDK.
Frequently asked questions
What is FDA product code DDK?
DDK is the FDA product code for beta-2-glycoprotein iii, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5440 and reviewed by the Immunology panel.
What device class is DDK?
Class I, regulation 21 CFR 866.5440. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DDK
- Run a recall and safety report across every DDK manufacturer
- Watch product code DDK 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.