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

    VZV BIO-ENZABEAD SCREEN KIT

    K Number: K833637 · Decision Feb 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    8
    Review Days
    116

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    Basic Information

    Device Name
    VZV BIO-ENZABEAD SCREEN KIT
    K Number
    K833637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bionetic Laboratory Products
    Date Received
    October 17, 1983
    Decision Date
    February 10, 1984
    Product Code
    LFY
    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
    LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

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