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

    MONO SCREENING TEST

    K Number: K830531 · Decision Mar 17, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    58
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    MONO SCREENING TEST
    K Number
    K830531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5640
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Tago, Inc.
    Date Received
    February 18, 1983
    Decision Date
    March 17, 1983
    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 Tago, Inc.

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    K834218 DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
    K840404 DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
    K833129 TAGO DIFFU-GEN-APOLIPOPROTEIN B-100
    K830611 RA SCREENING TEST
    K830156 HCG SCREENING TEST