Product code LEW— Clinical Toxicology
IMPREFLEX ALGINATE IMPRESSION MATERIAL
- Classification name
- Thin Layer Chromatography, Theophylline
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LEW
FDA has cleared device under product code LEW, all in 1977, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code LEW
Recent clearances under product code LEW
Data sourced from openFDA. This site is unofficial and independent of the FDA.