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

    EBV/VCA-CHECK(TM) ANTIGEN SLIDES

    K Number: K863408 · Decision Nov 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    19
    Applicant Total
    28
    Review Days
    86

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    Basic Information

    Device Name
    EBV/VCA-CHECK(TM) ANTIGEN SLIDES
    K Number
    K863408
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Technology, Inc.
    Date Received
    September 3, 1986
    Decision Date
    November 28, 1986
    Product Code
    GNP
    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
    GNP Antiserum, Cf, Epstein-Barr Virus

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