Clearance Summary
Rapid-i Kit received FDA 510(k) clearance under submission number K181461, sponsored by Vitrolife Sweden AB. 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 2019-01-04.
- Submission: K181461
- Applicant / Sponsor: Vitrolife Sweden AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2019-01-04
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.