DeviceClearance

Product code GOG— Microbiology

POLIO TYPE I CF ANTIGEN, & TYPE II, III

Classification name
Antisera, Cf, Poliovirus 1-3
Device class
Class 1
Regulation
21 CFR 866.3405
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

Market context for product code GOG

FDA has cleared 3 devices under product code GOG between 1985 and 2007, filed by 3 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 GOG

Recent clearances under product code GOG

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