DeviceClearance

Product code GOB— Microbiology

ROTASCREEN

Classification name
Antigens, Ha (Including Ha Control), Adenovirus 1-33
Device class
Class 1
Regulation
21 CFR 866.3020
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code GOB

FDA has cleared 1 device under product code GOB, all in 1987, 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 GOB

Recent clearances under product code GOB

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