FDA product code DBK: Fc, Fitc, Antigen, Antiserum, Control
DBK is the FDA product code for fc, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel. Devices under DBK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fc, Fitc, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5530 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DBK devices
openFDA lists no recalls for product code DBK.
Frequently asked questions
What is FDA product code DBK?
DBK is the FDA product code for fc, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel.
What device class is DBK?
Class I, regulation 21 CFR 866.5530. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DBK
- Run a recall and safety report across every DBK manufacturer
- Watch product code DBK 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times