LEW — Thin Layer Chromatography, Theophylline Class II
FDA product code LEW covers "Thin Layer Chromatography, Theophylline", a Class II medical device regulated under 21 CFR 862.3880. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LEW
- Device Class
- Class II
- Regulation Number
- 862.3880
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K771120 | espe dental products | IMPREFLEX ALGINATE IMPRESSION MATERIAL | August 3, 1977 |