QUJ · Class II · 21 CFR 884.6120

FDA Product Code QUJ: Automated Cryopreservation Storage System

To Provide An Automated Liquid Nitrogen Storage System For Oocytes, Embryos, And Sperm.

Leading manufacturers include Tmrw Life Sciences, Inc..

1
Total
1
Cleared
205d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Automated Cryopreservation Storage System Devices (Product Code QUJ)

1 devices
1–1 of 1

About Product Code QUJ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QUJ since 2022, with 1 receiving FDA clearance (average review time: 205 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QUJ devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →