SYSMEX CC-800— 510(k) K821575

Name: FDA 510(k) clearance K821575
Creator: U.S. Food and Drug Administration
Published: 1982-07-02

Substantially Equivalent

Sysmex/Toa Medical Electronics, Inc.

FDA 510(k) clearance K821575 for SYSMEX CC-800, Substantially Equivalent on 1982-07-02. Applicant: Sysmex/Toa Medical Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Sysmex/Toa Medical Electronics, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1982-05-27
Decision date: 1982-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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