DeviceClearance

Product code GNN— Microbiology

NYSTYMOGRAPH ACCESS

Classification name
Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
Device class
Class 1
Regulation
21 CFR 866.3145
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code GNN

FDA has cleared 1 device under product code GNN, all in 1982, 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 GNN

Recent clearances under product code GNN

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