FDA product code DOJ: Potassium Dichromate, Alcohol
DOJ is the FDA product code for potassium dichromate, alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DOJ, from 2 different applicants. The average 510(k) review took 142 days (median 142).
Classification
| Field | Value |
|---|---|
| Device name | Potassium Dichromate, Alcohol |
| Device class | Class II |
| Regulation | 21 CFR 862.3040 |
| 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 DOJ clearance
Top DOJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Toxi-Lab, Inc. | 1 | 1991-03-13 |
| Intersci Corp. | 1 | 1980-01-23 |
Most recent DOJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903223 | Toxi-Lab, Inc. | ON-SITE ALCOHOL | 1991-03-13 | 233 |
| K792469 | Intersci Corp. | INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS | 1980-01-23 | 51 |
Recalls for DOJ devices
openFDA lists no recalls for product code DOJ.
Frequently asked questions
What is FDA product code DOJ?
DOJ is the FDA product code for potassium dichromate, alcohol. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is DOJ?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOJ?
Across 2 cleared submissions the average was 142 days from receipt to decision (median 142).
Which companies have the most DOJ clearances?
Toxi-Lab, Inc. (1); Intersci Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOJ
- Run a recall and safety report across every DOJ manufacturer
- Watch product code DOJ 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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