FDA product code DGK: Igg, Fitc, Antigen, Antiserum, Control
DGK is the FDA product code for igg, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DGK, from 2 different applicants. The average 510(k) review took 32 days (median 32). FDA has posted 1 recall for DGK devices.
Classification
| Field | Value |
|---|---|
| Device name | Igg, Fitc, 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 DGK clearance
Top DGK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dako Corp. | 1 | 1983-07-18 |
| Intl. Diagnostic Technology | 1 | 1983-06-17 |
Most recent DGK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831908 | Dako Corp. | RABBIT ANTISERUM TO HUMAN IGG | 1983-07-18 | 34 |
| K831609 | Intl. Diagnostic Technology | FIAX IGG TEST KIT | 1983-06-17 | 30 |
Recalls for DGK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-01-18.
Frequently asked questions
What is FDA product code DGK?
DGK is the FDA product code for igg, fitc, 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 DGK?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DGK?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most DGK clearances?
Dako Corp. (1); Intl. Diagnostic Technology (1).
Have DGK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-01-18.
Next steps
- Run an FDA pathway report with predicate devices for product code DGK
- Run a recall and safety report across every DGK manufacturer
- Watch product code DGK 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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