FDA product code DAF: Gamma Globulin, Fitc, Antigen, Antiserum, Control
DAF is the FDA product code for gamma globulin, 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 1 510(k) submission under DAF. The average 510(k) review took 60 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Gamma Globulin, 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 DAF clearance
Top DAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boehringer Mannheim Corp. | 1 | 1987-05-15 |
Most recent DAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871027 | Boehringer Mannheim Corp. | PRECINORM(R) PROTEIN | 1987-05-15 | 60 |
Recalls for DAF devices
openFDA lists no recalls for product code DAF.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J1460 — Injection, gamma globulin, intramuscular, 1 cc
- J1560 — Injection, gamma globulin, intramuscular, over 10 cc
Frequently asked questions
What is FDA product code DAF?
DAF is the FDA product code for gamma globulin, 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 DAF?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAF?
Across 1 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most DAF clearances?
Boehringer Mannheim Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAF
- Run a recall and safety report across every DAF manufacturer
- Watch product code DAF 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 Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times