Product code KEY— Pathology

SLIDE STAINERS GLS 360 & 360-1

Classification name
Stainer, Tissue, Automated
Device class
Class 1
Regulation
21 CFR 864.3800
Advisory panel
Pathology
Total cleared
1
First cleared
Most recent

Market context for product code KEY

FDA has cleared 1 device under product code KEY, all in 1977, filed by 1 applicant company. 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.

Top applicants under product code KEY

Recent clearances under product code KEY

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