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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 the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2018-04-23 under 510(k) 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. The listed applicant is Sysmex America, Inc.. The 510(k) number is K171883.

When did Sysmex UF-5000 Fully Automated Urine Particle Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for Sysmex UF-5000 Fully Automated Urine Particle Analyzer?

The FDA 510(k) record lists Sysmex America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06951009Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy MenCOMPLETED

Other records listing Sysmex America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersK251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerK250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerK250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerK210346Sysmex XW-100 Automated Hematology Analyzer

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Related Devices (Code: LKM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252580iQ200 SeriesBeckman Coulter, Inc.K232416AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc.K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.K200811cobas u 701 microscopy analyzerRoche Diagnostics

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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