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

    AMEBIASIS BIO-ENZABEAD SCREEN KIT

    K Number: K831133 · Decision Jun 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    62

    Basic Information

    Device Name
    AMEBIASIS BIO-ENZABEAD SCREEN KIT
    K Number
    K831133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    BIONETIC LABORATORY PRODUCTS
    Date Received
    April 7, 1983
    Decision Date
    June 8, 1983
    Product Code
    KHW
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

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