Clearance Summary
PARADIGM LINK BLOOD GLUCOSE METER received FDA 510(k) clearance under submission number K040603, sponsored by Becton, Dickinson & CO. 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 2004-05-19.
- Submission: K040603
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2004-05-19
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.