Clearance Summary
ARCHITECT ROMA received FDA 510(k) clearance under submission number K151502, 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 2016-04-28.
- Submission: K151502
- Applicant / Sponsor: Fujirebio Diagnostics,Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 866.6050
- Decision date: 2016-04-28
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.