BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RESUBMITTED EBV/IGM-CHECK TEST KIT

    K Number: K890639 · Decision Jun 20, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    28
    Review Days
    132

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    Basic Information

    Device Name
    RESUBMITTED EBV/IGM-CHECK TEST KIT
    K Number
    K890639
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Technology, Inc.
    Date Received
    February 8, 1989
    Decision Date
    June 20, 1989
    Product Code
    LJN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJN Antibody Igm, If, Epstein-Barr Virus

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