Rubicon SA System
K-Number: K200654 · 2020-07-22
ApplicantDymedix Diagnostics, Inc.
Decision Date2020-07-22
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Rubicon SA System is a medical device manufactured by Dymedix Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-07-22 under approval number K200654. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Rubicon SA System?
Rubicon SA System is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Dymedix Diagnostics, Inc.. The 510(k) number is K200654.
When was Rubicon SA System approved by the FDA?
Rubicon SA System received FDA 510(k) clearance on 2020-07-22, under approval number K200654.
What company makes Rubicon SA System?
Rubicon SA System is manufactured by Dymedix Diagnostics, Inc..
What is the FDA product code for Rubicon SA System?
The FDA product code for Rubicon SA System is MNR.
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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.