QUJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Automated Cryopreservation Storage System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6120
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
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| Record | Firm | Date |
|---|---|---|
| CryoRobot Select System (K221086) | Tmrw Life Sciences, Inc. | 2022-11-04 |
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