Clearance Summary
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA received FDA 510(k) clearance under submission number K053552, sponsored by <Genx> Intl., Inc.. 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 2006-05-19.
- Submission: K053552
- Applicant / Sponsor: <Genx> Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2006-05-19
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.