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FDA 510(k)

iQ200 Series

K-Number: K252580 · 2025-09-10

ApplicantBeckman Coulter, Inc.
Decision Date2025-09-10
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

iQ200 Series is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-09-10 under 510(k) number K252580. 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 Series?

iQ200 Series is a medical device that received FDA 510(k) clearance on 2025-09-10. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K252580.

When did iQ200 Series receive FDA 510(k) clearance?

iQ200 Series received FDA 510(k) clearance on 2025-09-10, under 510(k) number K252580.

Who is the listed applicant for iQ200 Series?

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

What is the FDA product code for iQ200 Series?

The FDA product code for iQ200 Series is LKM.

Other records listing Beckman Coulter, 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.

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.

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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