DeviceClearance

Product code JGE— Clinical Chemistry

CARESIDE GLOBULIN

Classification name
Turbidimetric Method, Globulin
Device class
Class 1
Regulation
21 CFR 862.1330
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code JGE

FDA has cleared 1 device under product code JGE, all in 1998, 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 JGE

Recent clearances under product code JGE

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