FDA product code DFS: Igm, Fitc, Antigen, Antiserum, Control
DFS is the FDA product code for igm, fitc, 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 DFS. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Igm, Fitc, 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 |
Compare with all 510(k) review times · Search every DFS clearance
Top DFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dako Corp. | 1 | 1983-07-19 |
Most recent DFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831907 | Dako Corp. | RABBIT ANTISERUM TO HUMAN IGM | 1983-07-19 | 35 |
Recalls for DFS devices
openFDA lists no recalls for product code DFS.
Frequently asked questions
What is FDA product code DFS?
DFS is the FDA product code for igm, fitc, 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 DFS?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFS?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most DFS clearances?
Dako Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DFS
- Run a recall and safety report across every DFS manufacturer
- Watch product code DFS 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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