FDA product code DJN: Mercury Dithiazone, Colorimetry, Barbiturate
DJN is the FDA product code for mercury dithiazone, colorimetry, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJN. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Mercury Dithiazone, Colorimetry, Barbiturate |
| Device class | Class II |
| Regulation | 21 CFR 862.3150 |
| 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 DJN clearance
Top DJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stanbio Laboratory | 1 | 1982-11-29 |
Most recent DJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823237 | Stanbio Laboratory | BARBITURATE TEST SET #0550-050 | 1982-11-29 | 28 |
Recalls for DJN devices
openFDA lists no recalls for product code DJN.
Frequently asked questions
What is FDA product code DJN?
DJN is the FDA product code for mercury dithiazone, colorimetry, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel.
What device class is DJN?
Class II, regulation 21 CFR 862.3150. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJN?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most DJN clearances?
Stanbio Laboratory (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJN
- Run a recall and safety report across every DJN manufacturer
- Watch product code DJN 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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