Product code LAE— Clinical Toxicology
MOUTH-TO-MOUTH SHIELD APPLICATOR
- Classification name
- High Pressure Liquid Chromatography, Codeine
- Device class
- Class 2
- Regulation
- 21 CFR 862.3270
- Advisory panel
- Clinical Toxicology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LAE
FDA has cleared devices under product code LAE between 1983 and 1985, filed by 2 applicant companies. 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.
Clearances per year
- 1985
- 1983
Top applicants under product code LAE
Recent clearances under product code LAE
Data sourced from openFDA. This site is unofficial and independent of the FDA.