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FDA 510(k)

Sysmex UF-5000 Fully Automated Urine Particle Analyzer

K-Number: K171883 · 2018-04-23

ApplicantSysmex America, Inc.
Decision Date2018-04-23
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex UF-5000 Fully Automated Urine Particle Analyzer is a medical device manufactured by Sysmex America, Inc.. It received FDA 510(k) clearance on 2018-04-23 under approval number K171883. The device is classified under product code LKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sysmex UF-5000 Fully Automated Urine Particle Analyzer?

Sysmex UF-5000 Fully Automated Urine Particle Analyzer is a medical device that received FDA 510(k) clearance on 2018-04-23. It is manufactured by Sysmex America, Inc.. The 510(k) number is K171883.

When was Sysmex UF-5000 Fully Automated Urine Particle Analyzer approved by the FDA?

Sysmex UF-5000 Fully Automated Urine Particle Analyzer received FDA 510(k) clearance on 2018-04-23, under approval number K171883.

What company makes Sysmex UF-5000 Fully Automated Urine Particle Analyzer?

Sysmex UF-5000 Fully Automated Urine Particle Analyzer is manufactured by Sysmex America, Inc..

What is the FDA product code for Sysmex UF-5000 Fully Automated Urine Particle Analyzer?

The FDA product code for Sysmex UF-5000 Fully Automated Urine Particle Analyzer is LKM.

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Related Devices (Code: LKM)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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