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FDA 510(k)

iQ200 System, iChemVELOCITY Automated Urine Chemistry System

K-Number: K210127 · 2021-07-02

ApplicantBeckman Coulter, Inc.
Decision Date2021-07-02
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

iQ200 System, iChemVELOCITY Automated Urine Chemistry System is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2021-07-02 under approval number K210127. 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 iQ200 System, iChemVELOCITY Automated Urine Chemistry System?

iQ200 System, iChemVELOCITY Automated Urine Chemistry System is a medical device that received FDA 510(k) clearance on 2021-07-02. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K210127.

When was iQ200 System, iChemVELOCITY Automated Urine Chemistry System approved by the FDA?

iQ200 System, iChemVELOCITY Automated Urine Chemistry System received FDA 510(k) clearance on 2021-07-02, under approval number K210127.

What company makes iQ200 System, iChemVELOCITY Automated Urine Chemistry System?

iQ200 System, iChemVELOCITY Automated Urine Chemistry System is manufactured by Beckman Coulter, Inc..

What is the FDA product code for iQ200 System, iChemVELOCITY Automated Urine Chemistry System?

The FDA product code for iQ200 System, iChemVELOCITY Automated Urine Chemistry System is LKM.

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Related Devices (Code: LKM)

K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc. K200811cobas u 701 microscopy analyzerRoche Diagnostics K232416AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc. K252580iQ200 SeriesBeckman Coulter, 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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