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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2018-04-19 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K180693.
When was CoaguChek XS Pro System approved by the FDA?
CoaguChek XS Pro System received FDA 510(k) clearance on 2018-04-19, under approval number K180693.
What company makes CoaguChek XS Pro System?
CoaguChek XS Pro System is manufactured by Roche Diagnostics.
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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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.