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FDA 510(k)

CoaguChek XS Pro System

K-Number: K180693 · 2018-04-19

ApplicantRoche Diagnostics
Decision Date2018-04-19
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CoaguChek XS Pro 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 2018-04-19 under 510(k) number K180693. 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 Pro System?

CoaguChek XS Pro System is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Roche Diagnostics. The 510(k) number is K180693.

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

CoaguChek XS Pro System received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180693.

Who is the listed applicant for CoaguChek XS Pro 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 Pro System?

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

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Related Devices (Code: GJS)

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.

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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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