Genomadix Cube CYP2C19 System
K号: K220026 · 2023-03-21
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决定日期2023-03-21
产品代码NTI
咨询委员会TX
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决定实质等同
器械摘要
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.
常见问题
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.
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相关器械（代码：NTI）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
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