BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

    K Number: K190397 · Decision Nov 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    50
    Review Days
    269

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    Basic Information

    Device Name
    Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
    K Number
    K190397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3590
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunalysis Corporation
    Date Received
    February 19, 2019
    Decision Date
    November 15, 2019
    Product Code
    QBK
    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
    QBK Meprobamate Test System

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