Product code NGA— Clinical Chemistry

FERTELL FEMALE FERTILITY TEST

Classification name
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Device class
Class 1
Regulation
21 CFR 862.1300
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

Market context for product code NGA

FDA has cleared 2 devices under product code NGA between 2003 and 2007, filed by 2 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 NGA

Recent clearances under product code NGA

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