Clearance Summary
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control received FDA 510(k) clearance under submission number K151978, sponsored by Edan Instruments, Inc.. 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 2016-07-15.
- Submission: K151978
- Applicant / Sponsor: Edan Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1120
- Decision date: 2016-07-15
Classification & Regulation
This clearance is catalogued under FDA product code CHL and 21 CFR 862.1120, within the Clinical Chemistry review panel as a Class II device.