DeviceClearance

Sysmex UF-5000 Fully Automated Urine Particle Analyzer— 510(k) K171883

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K171883 for Sysmex UF-5000 Fully Automated Urine Particle Analyzer, Substantially Equivalent on 2018-04-23. Applicant: Sysmex America, Inc..

Clearance details

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.