Clearance Summary
PRESTIGE 24I; BIOLIS 24I; MGC 240 received FDA 510(k) clearance under submission number K103531, sponsored by Tokyo Boeki Medisys, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2011-12-01.
- Submission: K103531
- Applicant / Sponsor: Tokyo Boeki Medisys, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2011-12-01
Classification & Regulation
This clearance is catalogued under FDA product code CFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.