Clearance Summary
SYSMEX CC-800 received FDA 510(k) clearance under submission number K821575, sponsored by Sysmex/Toa Medical Electronics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1982-07-02.
- Submission: K821575
- Applicant / Sponsor: Sysmex/Toa Medical Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5200
- Decision date: 1982-07-02
Classification & Regulation
This clearance is catalogued under FDA product code GKL and 21 CFR 864.5200, within the Hematology review panel as a Class II device.