Clearance Summary
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) received FDA 510(k) clearance under submission number K232493, sponsored by Wuhan Huchuang Union Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2024-05-07.
- Submission: K232493
- Applicant / Sponsor: Wuhan Huchuang Union Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 2024-05-07
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.