FDA product code DJI: Antiserum, Gentamicin
DJI is the FDA product code for antiserum, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJI. The average 510(k) review took 13 days (median 13).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Gentamicin |
| Device class | Class II |
| Regulation | 21 CFR 862.3450 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DJI clearance
Top DJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kallestad Laboratories, Inc. | 1 | 1981-08-03 |
Most recent DJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812050 | Kallestad Laboratories, Inc. | KALLESTAD ANTISERA TO GENTAMICIN | 1981-08-03 | 13 |
Recalls for DJI devices
openFDA lists no recalls for product code DJI.
Frequently asked questions
What is FDA product code DJI?
DJI is the FDA product code for antiserum, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is DJI?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJI?
Across 1 cleared submissions the average was 13 days from receipt to decision (median 13).
Which companies have the most DJI clearances?
Kallestad Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJI
- Run a recall and safety report across every DJI manufacturer
- Watch product code DJI 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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