Clearance Summary
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance under submission number K133389, sponsored by Eps Bio Technology Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2014-04-15.
- Submission: K133389
- Applicant / Sponsor: Eps Bio Technology Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2014-04-15
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.