Clearance Summary
DUET SYSTEM received FDA 510(k) clearance under submission number K130775, sponsored by Bioview , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2014-05-09.
- Submission: K130775
- Applicant / Sponsor: Bioview , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.4700
- Decision date: 2014-05-09
Classification & Regulation
This clearance is catalogued under FDA product code NTH and 21 CFR 866.4700, within the Immunology review panel as a Class II device.