DeviceClearance

Product code JGX— Clinical Chemistry

LIPASE REAGENT SET

Classification name
Turbidimetric Method, Triglycerides
Device class
Class 1
Regulation
21 CFR 862.1705
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code JGX

FDA has cleared 1 device under product code JGX, all in 1983, 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 JGX

Recent clearances under product code JGX

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