FDA product code DGJ: Colostrum, Antigen, Antiserum, Control
DGJ is the FDA product code for colostrum, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5230 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DGJ. The average 510(k) review took 192 days (median 192).
Classification
| Field | Value |
|---|---|
| Device name | Colostrum, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5230 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DGJ clearance
Top DGJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 1 | 1989-08-25 |
Most recent DGJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890689 | Abbott Laboratories | ADX TM OPIATES | 1989-08-25 | 192 |
Recalls for DGJ devices
openFDA lists no recalls for product code DGJ.
Frequently asked questions
What is FDA product code DGJ?
DGJ is the FDA product code for colostrum, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5230 and reviewed by the Immunology panel.
What device class is DGJ?
Class I, regulation 21 CFR 866.5230. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DGJ?
Across 1 cleared submissions the average was 192 days from receipt to decision (median 192).
Which companies have the most DGJ clearances?
Abbott Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DGJ
- Run a recall and safety report across every DGJ manufacturer
- Watch product code DGJ 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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