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

    IBL C3D-CIC EIA TEST

    K Number: K032796 · Decision Jan 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    43
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    IBL C3D-CIC EIA TEST
    K Number
    K032796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ibl GmbH
    Date Received
    September 8, 2003
    Decision Date
    January 13, 2004
    Product Code
    CZW
    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
    CZW Complement C3, Antigen, Antiserum, Control

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    Other Clearances by Ibl GmbH

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    K041349 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
    K040923 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
    K033786 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
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