Clearance Summary
SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR received FDA 510(k) clearance under submission number K881165, sponsored by Sakura Finetek U.S.A., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1988-07-01.
- Submission: K881165
- Applicant / Sponsor: Sakura Finetek U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3875
- Decision date: 1988-07-01
Classification & Regulation
This clearance is catalogued under FDA product code IEO and 21 CFR 864.3875, within the Pathology review panel as a Class I device.