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FDA 510(k)

SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER

K-Number: K053135 · 2006-01-04

ApplicantSysmex America, Inc.
Decision Date2006-01-04
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX UF-100I AUTOMATED URINE CELL 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 2006-01-04 under 510(k) number K053135. 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-100I AUTOMATED URINE CELL ANALYZER?

SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER is a medical device that received FDA 510(k) clearance on 2006-01-04. The listed applicant is Sysmex America, Inc.. The 510(k) number is K053135.

When did SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER receive FDA 510(k) clearance?

SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER received FDA 510(k) clearance on 2006-01-04, under 510(k) number K053135.

Who is the listed applicant for SYSMEX UF-100I AUTOMATED URINE CELL 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-100I AUTOMATED URINE CELL ANALYZER?

The FDA product code for SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER is LKM.

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Other records listing Sysmex America, Inc. as applicant

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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 DiagnosticsK171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.K093861IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLEIris International, Inc.

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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