NGE · Class I · 21 CFR 862.1485

FDA Product Code NGE: Test, Luteinizing Hormone (lh), Over The Counter

Leading manufacturers include Unipath , Ltd..

6
Total
6
Cleared
104d
Avg days
1985
Since

FDA 510(k) Cleared Test, Luteinizing Hormone (lh), Over The Counter Devices (Product Code NGE)

6 devices
1–6 of 6
Cleared Feb 24, 1999
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
K990223
Unipath , Ltd.
Chemistry · 30d
Cleared Oct 28, 1998
CLEARPLAN EASY FERTILITY MONITOR
K981207
Unipath , Ltd.
Chemistry · 209d

About Product Code NGE - Regulatory Context