SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER— 510(k) K083002

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K083002 for SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER, Substantially Equivalent on 2009-02-03. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code LKM
Advisory panel: Hematology
Date received: 2008-10-08
Decision date: 2009-02-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Mundelein, IL, US

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