K182062

Substantially Equivalent

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

Applicant: Sysmex America, Inc.
Product code: JOY
Advisory panel: Hematology
Date received: 2018-08-01
Decision date: 2018-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

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