Clearance Summary
GLUCODR PLUS SYSTEM, MODEL AGM-3000 received FDA 510(k) clearance under submission number K082328, sponsored by All Medicus Co., 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 2009-02-27.
- Submission: K082328
- Applicant / Sponsor: All Medicus Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2009-02-27
Classification & Regulation
This clearance is catalogued under FDA product code NBW and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.