DeviceClearance

Product code GNL— Microbiology

ECHO TYPE 4 CF ANTIGEN

Classification name
Antigens, Cf (Including Cf Control), Echovirus 1-34
Device class
Class 1
Regulation
21 CFR 866.3205
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GNL

FDA has cleared 2 devices under product code GNL, all in 1985, 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 GNL

Recent clearances under product code GNL

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