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

    COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)

    K Number: K951639 · Decision Oct 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    58
    Review Days
    186

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    Basic Information

    Device Name
    COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
    K Number
    K951639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Incstar Corp.
    Date Received
    April 10, 1995
    Decision Date
    October 13, 1995
    Product Code
    DAE
    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
    DAE Complement C9, Antigen, Antiserum, Control

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