Cleared Traditional

Sysmex UF-5000 Fully Automated Urine Particle Analyzer

K171883 · Sysmex America, Inc. · Hematology
Apr 2018
Decision
304d
Days
Class 2
Risk

About This 510(k) Submission

K171883 is an FDA 510(k) clearance for the Sysmex UF-5000 Fully Automated Urine Particle Analyzer, a Counter, Urine Particle (Class II — Special Controls, product code LKM), submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on April 23, 2018, 304 days after receiving the submission on June 23, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K171883 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2017
Decision Date April 23, 2018
Days to Decision 304 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code LKM — Counter, Urine Particle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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