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

    Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

    K Number: K201442 · Decision Jul 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    48
    Applicant Total
    2
    Review Days
    60

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    Basic Information

    Device Name
    Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
    K Number
    K201442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diatron Group
    Date Received
    June 1, 2020
    Decision Date
    July 31, 2020
    Product Code
    LAF
    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
    LAF Gas Chromatography, Methamphetamine

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    Other Clearances by Diatron Group

    K Number Device Name
    K101741 DIATRON PICTUS 400