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FDA 510(k)

CoaguChek XS Plus System

K-Number: K253188 · 2025-10-24

ApplicantRoche Diagnostics
Decision Date2025-10-24
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CoaguChek XS Plus System is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K253188. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoaguChek XS Plus System?

CoaguChek XS Plus System is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Roche Diagnostics. The 510(k) number is K253188.

When did CoaguChek XS Plus System receive FDA 510(k) clearance?

CoaguChek XS Plus System received FDA 510(k) clearance on 2025-10-24, under 510(k) number K253188.

Who is the listed applicant for CoaguChek XS Plus System?

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

What is the FDA product code for CoaguChek XS Plus System?

The FDA product code for CoaguChek XS Plus System is GJS.

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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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