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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-12-25 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K170960.
When was CoaguChek Vantus System approved by the FDA?
CoaguChek Vantus System received FDA 510(k) clearance on 2017-12-25, under approval number K170960.
What company makes CoaguChek Vantus System?
CoaguChek Vantus System is manufactured by Roche Diagnostics.
What is the FDA product code for CoaguChek Vantus System?
The FDA product code for CoaguChek Vantus 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.