DeviceClearance

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device— 510(k) K182062

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K182062 for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device, Substantially Equivalent on 2018-10-30. Applicant: Sysmex America, Inc..

Clearance details

Applicant
Sysmex America, Inc.
Product code
Code JOY
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lincolnshire, IL, US
Download summary PDFView on FDA.gov ↗

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