Clearance Summary
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH received FDA 510(k) clearance under submission number K070047, sponsored by Nunc A/S. 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 2007-05-18.
- Submission: K070047
- Applicant / Sponsor: Nunc A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2007-05-18
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.