FDA product code DFG: Lambda, Rhodamine, Antigen, Antiserum, Control
DFG is the FDA product code for lambda, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DFG. The average 510(k) review took 20 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Lambda, 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 |
Top DFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aortech Critical Care , Ltd. | 1 | 2002-10-28 |
Most recent DFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023368 | Aortech Critical Care , Ltd. | TRUCATH.IP | 2002-10-28 | 20 |
Recalls for DFG devices
openFDA lists no recalls for product code DFG.
Frequently asked questions
What is FDA product code DFG?
DFG is the FDA product code for lambda, 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 DFG?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFG?
Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).
Which companies have the most DFG clearances?
Aortech Critical Care , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DFG
- Run a recall and safety report across every DFG manufacturer
- Watch product code DFG 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.