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

    AMER. HISTO-ID SYS PRIMARY IGM S7920-31

    K Number: K842327 · Decision Aug 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    35
    Review Days
    50

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    Basic Information

    Device Name
    AMER. HISTO-ID SYS PRIMARY IGM S7920-31
    K Number
    K842327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    June 13, 1984
    Decision Date
    August 2, 1984
    Product Code
    DFT
    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
    DFT Igm, Antigen, Antiserum, Control

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    K842830 IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
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    K842834 HEP-2 CELLS
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