FDA product code DND: Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
DND is the FDA product code for radioimmunoassay, digitoxin (125-i), rabbit antibody, solid phase sep.. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DND. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3300 |
| 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 DND clearance
Top DND applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smithkline Diagnostics, Inc. | 1 | 1976-07-16 |
Most recent DND clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760077 | Smithkline Diagnostics, Inc. | TEST, RIA, SERUM DIGOXIN | 1976-07-16 | 28 |
Recalls for DND devices
openFDA lists no recalls for product code DND.
Frequently asked questions
What is FDA product code DND?
DND is the FDA product code for radioimmunoassay, digitoxin (125-i), rabbit antibody, solid phase sep.. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel.
What device class is DND?
Class II, regulation 21 CFR 862.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code DND?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most DND clearances?
Smithkline Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DND
- Run a recall and safety report across every DND manufacturer
- Watch product code DND 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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