Clearance Summary
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) received FDA 510(k) clearance under submission number K160415, sponsored by Instrumentation Laboratory CO. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2016-12-14.
- Submission: K160415
- Applicant / Sponsor: Instrumentation Laboratory CO
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5600
- Decision date: 2016-12-14
Classification & Regulation
This clearance is catalogued under FDA product code GKF and 21 CFR 864.5600, within the Hematology review panel as a Class II device.