Clearance Summary
RAPID-I KIT received FDA 510(k) clearance under submission number K140207, 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 2014-12-18.
- Submission: K140207
- Applicant / Sponsor: Vitrolife Sweden AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2014-12-18
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.