FDA product code DFD: Kappa, Peroxidase, Antigen, Antiserum, Control
DFD is the FDA product code for kappa, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under DFD. The average 510(k) review took 453 days (median 148).
Classification
| Field | Value |
|---|---|
| Device name | Kappa, Peroxidase, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| 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 DFD clearance
Top DFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 3 | 1996-12-23 |
Most recent DFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940242 | Ventana Medical Systems, Inc. | VENTANA CEA PRIMARY ANTIBODY | 1996-12-23 | 1069 |
| K924578 | Ventana Medical Systems, Inc. | PSA ANTIBODY KIT | 1993-02-05 | 148 |
| K924629 | Ventana Medical Systems, Inc. | PAP ANTIBODY KIT | 1993-02-04 | 143 |
Recalls for DFD devices
openFDA lists no recalls for product code DFD.
Frequently asked questions
What is FDA product code DFD?
DFD is the FDA product code for kappa, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Pathology panel.
What device class is DFD?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFD?
Across 3 cleared submissions the average was 453 days from receipt to decision (median 148).
Which companies have the most DFD clearances?
Ventana Medical Systems, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code DFD
- Run a recall and safety report across every DFD manufacturer
- Watch product code DFD 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times