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

    BINDAZYME ANTI-DSDNA EIA KIT

    K Number: K993727 · Decision Dec 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    28
    Applicant Total
    115
    Review Days
    57

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    Basic Information

    Device Name
    BINDAZYME ANTI-DSDNA EIA KIT
    K Number
    K993727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    October 25, 1999
    Decision Date
    December 21, 1999
    Product Code
    LRM
    Advisory Committee
    Immunology
    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
    LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

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