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

    TIA-IGM REAGENT & CALIBRATOR SETS

    K Number: K831103 · Decision Apr 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    19
    Review Days
    22

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    Basic Information

    Device Name
    TIA-IGM REAGENT & CALIBRATOR SETS
    K Number
    K831103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Worthington Diagnostic Systems
    Date Received
    April 5, 1983
    Decision Date
    April 27, 1983
    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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