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FDA 510(k)

939UDX URINE PATHOLOGY SYSTEM

K-Number: K000373 · 2000-04-14

ApplicantIntl. Remote Imaging Systems
Decision Date2000-04-14
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

939UDX URINE PATHOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Remote Imaging Systems. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K000373. 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 939UDX URINE PATHOLOGY SYSTEM?

939UDX URINE PATHOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K000373.

When did 939UDX URINE PATHOLOGY SYSTEM receive FDA 510(k) clearance?

939UDX URINE PATHOLOGY SYSTEM received FDA 510(k) clearance on 2000-04-14, under 510(k) number K000373.

Who is the listed applicant for 939UDX URINE PATHOLOGY SYSTEM?

The FDA 510(k) record lists Intl. Remote Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 939UDX URINE PATHOLOGY SYSTEM?

The FDA product code for 939UDX URINE PATHOLOGY SYSTEM is LKM.

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Other records listing Intl. Remote Imaging Systems 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.

K022774IQ 200 SYSTEMK972141THE YELLOW IRIS URINALYSIS WORKSTATIONK953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZERK960054900UDX URINE PATHOLOGY SYSTEMK954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITYK943463THE YELLOW IRIS

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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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