FDA product code DJS: U.V. Light, Tlc
DJS is the FDA product code for u.v. light, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJS. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | U.V. Light, Tlc |
| Device class | Class I |
| Regulation | 21 CFR 862.2270 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every DJS clearance
Top DJS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technilab | 1 | 1977-08-22 |
Most recent DJS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771486 | Technilab | DUAL LAB-LITE LIGHT BOX | 1977-08-22 | 21 |
Recalls for DJS devices
openFDA lists no recalls for product code DJS.
Frequently asked questions
What is FDA product code DJS?
DJS is the FDA product code for u.v. light, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is DJS?
Class I, regulation 21 CFR 862.2270. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DJS?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most DJS clearances?
Technilab (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJS
- Run a recall and safety report across every DJS manufacturer
- Watch product code DJS 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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