QKE · Class I · 21 CFR 862.1620

FDA Product Code QKE: Immunoassay, Pregnanediol Glucuronide, Over The Counter

Over-the-counter Detection Of Pregnanediol Glucuronide For The Confirmation Of Ovulation

Leading manufacturers include Mfb Fertility, Inc..

1
Total
1
Cleared
269d
Avg days
2020
Since

FDA 510(k) Cleared Immunoassay, Pregnanediol Glucuronide, Over The Counter Devices (Product Code QKE)

1 devices
1–1 of 1
Cleared Feb 27, 2020
Proov Test
K191462
Mfb Fertility, Inc.
Chemistry · 269d

About Product Code QKE - Regulatory Context