NGA · Class I · 21 CFR 862.1300

FDA Product Code NGA: Test, Follicle Stimulating Hormone (fsh), Over The Counter

Leading manufacturers include Genosis, Inc. and Quantrx Biomedical Corporation.

2
Total
2
Cleared
185d
Avg days
2003
Since

FDA 510(k) Cleared Test, Follicle Stimulating Hormone (fsh), Over The Counter Devices (Product Code NGA)

2 devices
1–2 of 2
Cleared Oct 22, 2007
QUANTRX FEMALE FERTILITY TEST
K070484
Quantrx Biomedical Corporation
Chemistry · 244d
Cleared Oct 30, 2003
FERTELL FEMALE FERTILITY TEST
K032002
Genosis, Inc.
Chemistry · 125d

About Product Code NGA - Regulatory Context