NGE · Class I · 21 CFR 862.1485

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

Leading manufacturers include Unipath , Ltd., Pheromone Sciences Corp. and Zetek, Inc..

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 Sep 23, 2002
FERTILITE OV
K020808
Pheromone Sciences Corp.
Toxicology · 195d
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
Cleared Jan 07, 1998
OVULON MONITOR
K973860
Conception Technology, Inc.
Toxicology · 90d
Cleared Oct 14, 1986
PEAK OVULATION PREDICTOR
K863121
Micron Technology, Inc.
Toxicology · 61d
Cleared Mar 22, 1985
CUE FERTILITY MONITOR
K850579
Zetek, Inc.
Toxicology · 37d

About Product Code NGE - Regulatory Context