FDA product code DFK: Igg (Fab Fragment Specific), Antigen, Antiserum, Control
DFK is the FDA product code for igg (fab fragment specific), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under DFK. The average 510(k) review took 63 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Igg (Fab Fragment Specific), Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5520 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DFK clearance
Top DFK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kent Laboratories, Inc. | 3 | 1979-09-04 |
Most recent DFK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790711 | Kent Laboratories, Inc. | ANTISERA TO HUMAN FRAGMENT | 1979-09-04 | 145 |
| K771243 | Kent Laboratories, Inc. | ANTISERA TO HUMAN FAB FRAGMENT | 1977-08-03 | 23 |
| K770670 | Kent Laboratories, Inc. | FLOR. CONJUG. HUMAN FAB FRAGMENT | 1977-04-28 | 20 |
Recalls for DFK devices
openFDA lists no recalls for product code DFK.
Frequently asked questions
What is FDA product code DFK?
DFK is the FDA product code for igg (fab fragment specific), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel.
What device class is DFK?
Class I, regulation 21 CFR 866.5520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DFK?
Across 3 cleared submissions the average was 63 days from receipt to decision (median 23).
Which companies have the most DFK clearances?
Kent Laboratories, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code DFK
- Run a recall and safety report across every DFK manufacturer
- Watch product code DFK 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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