BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Genomadix Cube CYP2C19 System

    K Number: K220026 · Decision Mar 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    440

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    Basic Information

    Device Name
    Genomadix Cube CYP2C19 System
    K Number
    K220026
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genomadix, Inc.
    Date Received
    January 5, 2022
    Decision Date
    March 21, 2023
    Product Code
    NTI
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NTI Drug Metabolizing Enzyme Genotyping Systems

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