Clearance Summary
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set received FDA 510(k) clearance under submission number K173202, sponsored by Sekisui Medical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2018-05-09.
- Submission: K173202
- Applicant / Sponsor: Sekisui Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2018-05-09
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.