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

    METHAQUALONE ENZYME IMMUNOASSAY

    K Number: K940123 · Decision May 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    66
    Review Days
    113

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    Basic Information

    Device Name
    METHAQUALONE ENZYME IMMUNOASSAY
    K Number
    K940123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3630
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Reagents, Inc.
    Date Received
    January 10, 1994
    Decision Date
    May 3, 1994
    Product Code
    KXS
    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
    KXS Radioimmunoassay, Methaqualone

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