FDA product code DGH: Igd, Peroxidase, Antigen, Antiserum, Control
DGH is the FDA product code for igd, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under DGH. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Igd, Peroxidase, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DGH clearance
Top DGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biotest-Serum-Institut | 1 | 1981-08-12 |
Most recent DGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812076 | Biotest-Serum-Institut | ANTI-GM & ANTI-KM TYPING SERUMS | 1981-08-12 | 21 |
Recalls for DGH devices
openFDA lists no recalls for product code DGH.
Frequently asked questions
What is FDA product code DGH?
DGH is the FDA product code for igd, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Pathology panel.
What device class is DGH?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DGH?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most DGH clearances?
Biotest-Serum-Institut (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DGH
- Run a recall and safety report across every DGH manufacturer
- Watch product code DGH 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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