FDA product code DDD: Transferrin, Rhodamine, Antigen, Antiserum, Control
DDD is the FDA product code for transferrin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DDD. The average 510(k) review took 178 days (median 178). FDA has posted 1 recall for DDD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Transferrin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5880 |
| 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 DDD clearance
Top DDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus America, Inc. | 1 | 1997-02-06 |
Most recent DDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963139 | Olympus America, Inc. | OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT | 1997-02-06 | 178 |
Recalls for DDD devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-06.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code DDD?
DDD is the FDA product code for transferrin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel.
What device class is DDD?
Class II, regulation 21 CFR 866.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code DDD?
Across 1 cleared submissions the average was 178 days from receipt to decision (median 178).
Which companies have the most DDD clearances?
Olympus America, Inc. (1).
Have DDD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-09-06.
Next steps
- Run an FDA pathway report with predicate devices for product code DDD
- Run a recall and safety report across every DDD manufacturer
- Watch product code DDD 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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