FDA product code DJK: Digitoxin Control Serum, Ria
DJK is the FDA product code for digitoxin control serum, ria. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJK. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Digitoxin Control Serum, Ria |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DJK clearance
Top DJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 1 | 1978-04-10 |
Most recent DJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780495 | Diagnostic Products Corp. | DIGITOXIN | 1978-04-10 | 14 |
Recalls for DJK devices
openFDA lists no recalls for product code DJK.
Frequently asked questions
What is FDA product code DJK?
DJK is the FDA product code for digitoxin control serum, ria. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is DJK?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DJK?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most DJK clearances?
Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJK
- Run a recall and safety report across every DJK manufacturer
- Watch product code DJK 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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