FDA product code DJE: Thin Layer Chromatography, Salicylate
DJE is the FDA product code for thin layer chromatography, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJE. The average 510(k) review took 11 days (median 11).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Salicylate |
| Device class | Class II |
| Regulation | 21 CFR 862.3830 |
| 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 DJE clearance
Top DJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1980-10-31 |
Most recent DJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802615 | Syva Co. | EMIT-STM OPIATE ASSAY | 1980-10-31 | 11 |
Recalls for DJE devices
openFDA lists no recalls for product code DJE.
Frequently asked questions
What is FDA product code DJE?
DJE is the FDA product code for thin layer chromatography, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel.
What device class is DJE?
Class II, regulation 21 CFR 862.3830. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJE?
Across 1 cleared submissions the average was 11 days from receipt to decision (median 11).
Which companies have the most DJE clearances?
Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJE
- Run a recall and safety report across every DJE manufacturer
- Watch product code DJE 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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