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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 a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-09-10 under approval 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. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K252580.

When was iQ200 Series approved by the FDA?

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

What company makes iQ200 Series?

iQ200 Series is manufactured by Beckman Coulter, Inc..

What is the FDA product code for iQ200 Series?

The FDA product code for iQ200 Series is LKM.

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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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