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.. Device class: 2.

Clearance details

Applicant
Sysmex America, Inc.
Product code
Code LKM
Device class
Class 2
Regulation
21 CFR 864.5200
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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