BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇴 Jordan

    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

    K Number: K191099 · Decision Oct 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    2
    Review Days
    161

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    Basic Information

    Device Name
    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
    K Number
    K191099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atlas Medical
    Date Received
    April 25, 2019
    Decision Date
    October 3, 2019
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Atlas Medical

    K Number Device Name
    K102760 ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001