Clearance Summary
DUET SYSTEM received FDA 510(k) clearance under submission number K040591, sponsored by Bioview , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-09-16.
- Submission: K040591
- Applicant / Sponsor: Bioview , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 2004-09-16
Classification & Regulation
This clearance is catalogued under FDA product code JOY and 21 CFR 864.5260, within the Hematology review panel as a Class II device.