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

    BOEHRINGER MANNHEIM IGG ASSAY

    K Number: K955906 · Decision Feb 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    340
    Review Days
    42

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    Basic Information

    Device Name
    BOEHRINGER MANNHEIM IGG ASSAY
    K Number
    K955906
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    December 29, 1995
    Decision Date
    February 9, 1996
    Product Code
    DFZ
    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
    DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control

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