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

    N PROTEIN STANDARD SY

    K Number: K952594 · Decision Jul 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    43
    Applicant Total
    145
    Review Days
    41

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    Basic Information

    Device Name
    N PROTEIN STANDARD SY
    K Number
    K952594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    June 6, 1995
    Decision Date
    July 17, 1995
    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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