Clearance Summary
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM received FDA 510(k) clearance under submission number K882767, sponsored by Toa Medical Electronics USA, 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 1988-07-18.
- Submission: K882767
- Applicant / Sponsor: Toa Medical Electronics USA, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.5240
- Decision date: 1988-07-18
Classification & Regulation
This clearance is catalogued under FDA product code GKH and 21 CFR 864.5240, within the Hematology review panel as a Class I device.