SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER— 510(k) K053135

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K053135 for SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER, Substantially Equivalent on 2006-01-04. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code LKM
Advisory panel: Hematology
Date received: 2005-11-08
Decision date: 2006-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

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