Clearance Summary
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe received FDA 510(k) clearance under submission number K191396, sponsored by HORIBA ABX SAS. 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 2019-07-26.
- Submission: K191396
- Applicant / Sponsor: HORIBA ABX SAS
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1145
- Decision date: 2019-07-26
Classification & Regulation
This clearance is catalogued under FDA product code CJY and 21 CFR 862.1145, within the Clinical Chemistry review panel as a Class II device.