DeviceClearance

Product code NGE— Clinical Chemistry

CLEARPLAN EASY FERTILITY MONITOR

Classification name
Test, Luteinizing Hormone (Lh), Over The Counter
Device class
Class 1
Regulation
21 CFR 862.1485
Advisory panel
Clinical Chemistry
Total cleared
6
First cleared
Most recent

Market context for product code NGE

FDA has cleared 6 devices under product code NGE between 1985 and 2002, filed by 5 applicant companies. 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.

Clearances per year

Top applicants under product code NGE

Recent clearances under product code NGE

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