SYSMEX MODEL UF1000I— 510(k) K070910

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K070910 for SYSMEX MODEL UF1000I, Substantially Equivalent on 2007-05-25. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code LKM
Advisory panel: Hematology
Date received: 2007-04-02
Decision date: 2007-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

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