510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QUJClass II

Automated Cryopreservation Storage System

21 CFR 884.6120 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

QUJ is the FDA product code for Automated Cryopreservation Storage System, a class II device type, regulated under 21 CFR 884.6120. FDA's definition for this code reads: "To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QUJ
Device name
Automated Cryopreservation Storage System
FDA definition
To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QUJ

By decision year
1 clearance under product code QUJ with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QUJ by decision year
YearClearances
20221

Applicants with the most clearances

Product code QUJ
Applicants holding the most 510(k) clearances under product code QUJ
ApplicantClearances
TMRW LIFE SCIENCES, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code