Clearance Summary
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator received FDA 510(k) clearance under submission number K160225, sponsored by Instrumentation Laboratory 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 2016-12-14.
- Submission: K160225
- Applicant / Sponsor: Instrumentation Laboratory CO
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1665
- Decision date: 2016-12-14
Classification & Regulation
This clearance is catalogued under FDA product code JGS and 21 CFR 862.1665, within the Clinical Chemistry review panel as a Class II device.