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 a medical device manufactured by Genomadix, Inc.. It received FDA 510(k) clearance on 2023-03-21 under approval 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. It is manufactured by Genomadix, Inc.. The 510(k) number is K220026.
When was Genomadix Cube CYP2C19 System approved by the FDA?
Genomadix Cube CYP2C19 System received FDA 510(k) clearance on 2023-03-21, under approval number K220026.
What company makes Genomadix Cube CYP2C19 System?
Genomadix Cube CYP2C19 System is manufactured by Genomadix, Inc..
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)
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.