FDA product code DFF: Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
DFF is the FDA product code for alpha-1-antichymotrypsin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5080 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DFF. The average 510(k) review took 133 days (median 133).
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5080 |
| 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 DFF clearance
Top DFF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cooper Biomedical, Inc. | 1 | 1987-02-13 |
Most recent DFF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863868 | Cooper Biomedical, Inc. | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT | 1987-02-13 | 133 |
Recalls for DFF devices
openFDA lists no recalls for product code DFF.
Frequently asked questions
What is FDA product code DFF?
DFF is the FDA product code for alpha-1-antichymotrypsin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5080 and reviewed by the Immunology panel.
What device class is DFF?
Class II, regulation 21 CFR 866.5080. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFF?
Across 1 cleared submissions the average was 133 days from receipt to decision (median 133).
Which companies have the most DFF clearances?
Cooper Biomedical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DFF
- Run a recall and safety report across every DFF manufacturer
- Watch product code DFF 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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