FDA product code DJQ: Test Reagents For Phenothiazine
DJQ is the FDA product code for test reagents for phenothiazine. It is a Class II device, regulated under 21 CFR 862.3670 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJQ. The average 510(k) review took 247 days (median 247).
Classification
| Field | Value |
|---|---|
| Device name | Test Reagents For Phenothiazine |
| Device class | Class II |
| Regulation | 21 CFR 862.3670 |
| 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 DJQ clearance
Top DJQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polystan C/O Vitalcor, Inc. | 1 | 1990-03-28 |
Most recent DJQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894657 | Polystan C/O Vitalcor, Inc. | POLYSTAN HEART-LUNG MACHINE SYSTEM | 1990-03-28 | 247 |
Recalls for DJQ devices
openFDA lists no recalls for product code DJQ.
Frequently asked questions
What is FDA product code DJQ?
DJQ is the FDA product code for test reagents for phenothiazine. It is a Class II device, regulated under 21 CFR 862.3670 and reviewed by the Clinical Toxicology panel.
What device class is DJQ?
Class II, regulation 21 CFR 862.3670. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJQ?
Across 1 cleared submissions the average was 247 days from receipt to decision (median 247).
Which companies have the most DJQ clearances?
Polystan C/O Vitalcor, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJQ
- Run a recall and safety report across every DJQ manufacturer
- Watch product code DJQ 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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