Clearance Summary
Lumipulse G ROMA received FDA 510(k) clearance under submission number K160090, sponsored by Fujirebio Diagnostics,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 2016-05-16.
- Submission: K160090
- Applicant / Sponsor: Fujirebio Diagnostics,Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 866.6050
- Decision date: 2016-05-16
Classification & Regulation
This clearance is catalogued under FDA product code ONX and 21 CFR 866.6050, within the Obstetrics/Gynecology review panel as a Class II device.