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FDA 510(k)

AUTION EYE AI-4510 Urine Particle Analysis System

K-Number: K232416 · 2024-05-03

ApplicantArkray, Inc.
Decision Date2024-05-03
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTION EYE AI-4510 Urine Particle Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K232416. 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 AUTION EYE AI-4510 Urine Particle Analysis System?

AUTION EYE AI-4510 Urine Particle Analysis System is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Arkray, Inc.. The 510(k) number is K232416.

When did AUTION EYE AI-4510 Urine Particle Analysis System receive FDA 510(k) clearance?

AUTION EYE AI-4510 Urine Particle Analysis System received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232416.

Who is the listed applicant for AUTION EYE AI-4510 Urine Particle Analysis System?

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

What is the FDA product code for AUTION EYE AI-4510 Urine Particle Analysis System?

The FDA product code for AUTION EYE AI-4510 Urine Particle Analysis System is LKM.

Other records listing Arkray, 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.

K193514AUTION MAX AX-4060 Urinalysis SystemK221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceK200788Assure Titanium Blood Glucose Monitoring SystemK160062AUTION ELEVEN Semi-Automated Urinalysis System

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.K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.K200811cobas u 701 microscopy analyzerRoche DiagnosticsK171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.

Official Source

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

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