FDA product code DNJ: Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
DNJ is the FDA product code for radioimmunoassay, digoxin (125-i), goat antibody, 2nd antibody sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DNJ, from 2 different applicants. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| 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 DNJ clearance
Top DNJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Antibodies, Inc. | 1 | 1977-10-21 |
| G.D. Searle and Co. | 1 | 1977-08-25 |
Most recent DNJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771877 | Antibodies, Inc. | DIGOXIN RIA KIT | 1977-10-21 | 17 |
| K771533 | G.D. Searle and Co. | DIGOXIN RIA KIT | 1977-08-25 | 15 |
Recalls for DNJ devices
openFDA lists no recalls for product code DNJ.
Frequently asked questions
What is FDA product code DNJ?
DNJ is the FDA product code for radioimmunoassay, digoxin (125-i), goat antibody, 2nd antibody sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DNJ?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DNJ?
Across 2 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most DNJ clearances?
Antibodies, Inc. (1); G.D. Searle and Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DNJ
- Run a recall and safety report across every DNJ manufacturer
- Watch product code DNJ 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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