Clearance Summary
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance under submission number K112272, 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 2011-09-07.
- Submission: K112272
- 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: 2011-09-07
Classification & Regulation
This clearance is catalogued under FDA product code LFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.