Clearance Summary
PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 received FDA 510(k) clearance under submission number K040958, sponsored by Tokyo Boeki Medical System , Ltd.. 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 2005-02-15.
- Submission: K040958
- Applicant / Sponsor: Tokyo Boeki Medical System , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 2005-02-15
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.