DeviceClearance

Product code LEB— Pathology

CLEAR-MOUNT

Classification name
Mounting Media
Device class
Class 1
Regulation
21 CFR 864.4010
Advisory panel
Pathology
Total cleared
5
First cleared
Most recent

Market context for product code LEB

FDA has cleared 5 devices under product code LEB between 1976 and 1984, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code LEB

Recent clearances under product code LEB

Data sourced from openFDA. This site is unofficial and independent of the FDA.