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

    IBL C1Q-CIC CIA TEST

    K Number: K032254 · Decision Aug 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    27
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    IBL C1Q-CIC CIA TEST
    K Number
    K032254
    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
    July 22, 2003
    Decision Date
    August 29, 2003
    Product Code
    DAK
    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
    DAK Complement C1q, Antigen, Antiserum, Control

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