Clearance Summary
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- received FDA 510(k) clearance under submission number K850239, 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 1985-04-01.
- Submission: K850239
- Applicant / Sponsor: Toa Medical Electronics USA, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8200
- Decision date: 1985-04-01
Classification & Regulation
This clearance is catalogued under FDA product code GIF and 21 CFR 864.8200, within the Hematology review panel as a Class I device.