FDA product code DGD: Igg, Ferritin, Antigen, Antiserum, Control
DGD is the FDA product code for igg, ferritin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under DGD, from 3 different applicants. The average 510(k) review took 45 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Igg, Ferritin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DGD clearance
Top DGD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clinical Controls, Inc. | 1 | 1995-02-10 |
| Abbott Laboratories | 1 | 1988-05-11 |
| Mallinckrodt Critical Care | 1 | 1983-03-09 |
Most recent DGD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K946266 | Clinical Controls, Inc. | FERRITIN CONTROL - LEVEL 1, 2, 3 | 1995-02-10 | 49 |
| K881345 | Abbott Laboratories | IMX FERRITIN | 1988-05-11 | 42 |
| K830229 | Mallinckrodt Critical Care | ROENTGENOGRAPHY SET | 1983-03-09 | 44 |
Recalls for DGD devices
openFDA lists no recalls for product code DGD.
Frequently asked questions
What is FDA product code DGD?
DGD is the FDA product code for igg, ferritin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is DGD?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DGD?
Across 3 cleared submissions the average was 45 days from receipt to decision (median 44).
Which companies have the most DGD clearances?
Clinical Controls, Inc. (1); Abbott Laboratories (1); Mallinckrodt Critical Care (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DGD
- Run a recall and safety report across every DGD manufacturer
- Watch product code DGD 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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