DeviceClearance

Product code JLH— Clinical Chemistry

ELVI NON-ESTERIFIED FATTY ACIDS

Classification name
Titrimetric, Fatty Acids
Device class
Class 1
Regulation
21 CFR 862.1290
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code JLH

FDA has cleared 1 device under product code JLH, all in 1980, 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 JLH

Recent clearances under product code JLH

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