QUJ — Automated Cryopreservation Storage System Class II
FDA product code QUJ covers "Automated Cryopreservation Storage System", a Class II medical device regulated under 21 CFR 884.6120. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QUJ
- Device Class
- Class II
- Regulation Number
- 884.6120
- Submission Type
- 510(k) Exempt
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221086 | Tmrw Life Sciences | CryoRobot Select System | Nov 4, 2022 |