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FDA 510(k)

Rubicon SA System

K-Number: K200654 · 2020-07-22

Decision Date2020-07-22
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Rubicon SA System is the device name listed in this FDA 510(k) record. The listed applicant is Dymedix Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-07-22 under 510(k) 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. The listed applicant is Dymedix Diagnostics, Inc.. The 510(k) number is K200654.

When did Rubicon SA System receive FDA 510(k) clearance?

Rubicon SA System received FDA 510(k) clearance on 2020-07-22, under 510(k) number K200654.

Who is the listed applicant for Rubicon SA System?

The FDA 510(k) record lists Dymedix Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rubicon SA System?

The FDA product code for Rubicon SA System is MNR.

Other records listing Dymedix Diagnostics, Inc. as applicant

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.

Related Devices (Code: MNR)

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.

Official Source

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