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FDA 510(k)

CoaguChek Vantus System

K-Number: K170960 · 2017-12-25

ApplicantRoche Diagnostics
Decision Date2017-12-25
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CoaguChek Vantus 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 2017-12-25 under 510(k) number K170960. 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 Vantus System?

CoaguChek Vantus System is a medical device that received FDA 510(k) clearance on 2017-12-25. The listed applicant is Roche Diagnostics. The 510(k) number is K170960.

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

CoaguChek Vantus System received FDA 510(k) clearance on 2017-12-25, under 510(k) number K170960.

Who is the listed applicant for CoaguChek Vantus 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 Vantus System?

The FDA product code for CoaguChek Vantus 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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