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FDA 510(k)

Genomadix Cube CYP2C19 System

K-Number: K220026 · 2023-03-21

ApplicantGenomadix, Inc.
Decision Date2023-03-21
Product CodeNTI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Genomadix Cube CYP2C19 System is the device name listed in this FDA 510(k) record. The listed applicant is Genomadix, Inc.. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K220026. The device is classified under product code NTI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genomadix Cube CYP2C19 System?

Genomadix Cube CYP2C19 System is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Genomadix, Inc.. The 510(k) number is K220026.

When did Genomadix Cube CYP2C19 System receive FDA 510(k) clearance?

Genomadix Cube CYP2C19 System received FDA 510(k) clearance on 2023-03-21, under 510(k) number K220026.

Who is the listed applicant for Genomadix Cube CYP2C19 System?

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

What is the FDA product code for Genomadix Cube CYP2C19 System?

The FDA product code for Genomadix Cube CYP2C19 System is NTI.

Related Devices (Code: NTI)

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.

K170492xTAG CYP2D6 Kit v3Luminex Molecular Diagnostics, Inc.

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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