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

    LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207

    K Number: K984476 · Decision Dec 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    319
    Review Days
    6

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    Basic Information

    Device Name
    LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
    K Number
    K984476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad
    Date Received
    December 16, 1998
    Decision Date
    December 22, 1998
    Product Code
    LKO
    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
    LKO Anti-Rnp Antibody, Antigen And Control

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