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

    TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL

    K Number: K922726 · Decision Oct 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    58
    Applicant Total
    5
    Review Days
    122

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    Basic Information

    Device Name
    TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
    K Number
    K922726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5640
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Simplicity Diagnostics, Inc.
    Date Received
    June 5, 1992
    Decision Date
    October 5, 1992
    Product Code
    KTN
    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
    KTN System, Test, Infectious Mononucleosis

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    Other Clearances by Simplicity Diagnostics, Inc.

    K Number Device Name
    K970100 TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
    K922725 TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL
    K922722 TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
    K922723 TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL