Clearance Summary
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode received FDA 510(k) clearance under submission number K183375, sponsored by Horiba, Ltd.. 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 2019-02-12.
- Submission: K183375
- Applicant / Sponsor: Horiba, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 2019-02-12
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.