FDA product code LEW: Thin Layer Chromatography, Theophylline
LEW is the FDA product code for thin layer chromatography, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under LEW. The average 510(k) review took 42 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Theophylline |
| Device class | Class II |
| Regulation | 21 CFR 862.3880 |
| 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 LEW clearance
Top LEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Espe Dental Products | 1 | 1977-08-03 |
Most recent LEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771120 | Espe Dental Products | IMPREFLEX ALGINATE IMPRESSION MATERIAL | 1977-08-03 | 42 |
Recalls for LEW devices
openFDA lists no recalls for product code LEW.
Frequently asked questions
What is FDA product code LEW?
LEW is the FDA product code for thin layer chromatography, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel.
What device class is LEW?
Class II, regulation 21 CFR 862.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code LEW?
Across 1 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most LEW clearances?
Espe Dental Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEW
- Run a recall and safety report across every LEW manufacturer
- Watch product code LEW 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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