Clearance Summary
ROMA (HE4 EIA + ARCHITECT CA 125 II) received FDA 510(k) clearance under submission number K103358, 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 2011-09-01.
- Submission: K103358
- Applicant / Sponsor: Fujirebio Diagnostics,Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 866.6050
- Decision date: 2011-09-01
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.