SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR— 510(k) K881165

Name: FDA 510(k) clearance K881165
Creator: U.S. Food and Drug Administration
Published: 1988-07-01

Substantially Equivalent

Sakura Finetek U.S.A., Inc.

FDA 510(k) clearance K881165 for SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR, Substantially Equivalent on 1988-07-01. Applicant: Sakura Finetek U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Sakura Finetek U.S.A., Inc.
Product code: Code IEO
Device class: Class 1
Regulation: 21 CFR 864.3875
Advisory panel: Pathology
Date received: 1988-03-20
Decision date: 1988-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IEO

product code IEO

Injury: 326
Total: 326

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.