Product code NFX— Clinical Chemistry

LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR

Classification name
Test, Cholesterol, Total, Over The Counter
Device class
Class 1
Regulation
21 CFR 862.1175
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code NFX

FDA has cleared 1 device under product code NFX, all in 2004, 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 NFX

Recent clearances under product code NFX

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