SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE— 510(k) K080887

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K080887 for SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE, Substantially Equivalent on 2008-05-02. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code LKM
Advisory panel: Hematology
Date received: 2008-03-31
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mundelein, IL, US

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