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

    EBNA STAT TEST KIT

    K Number: K911473 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    30
    Review Days
    174

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    Basic Information

    Device Name
    EBNA STAT TEST KIT
    K Number
    K911473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Whittaker Bioproducts, Inc.
    Date Received
    April 4, 1991
    Decision Date
    September 25, 1991
    Product Code
    LLM
    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
    LLM Test, Antigen, Nuclear, Epstein-Barr Virus

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    Other Clearances by Whittaker Bioproducts, Inc.

    K Number Device Name
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    K913212 3M IGE SINGLE POINT FAST TEST
    K904652 LYME STAT M TEST KIT
    K904893 FIAX LYME M TEST KIT
    K905468 PYLORI-G FIAX TEST KIT
    K904738 PYLORI STAT TEST KIT
    K901493 FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
    K893579 FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
    K894932 FIAX EB VCA-M TEST KIT
    K894235 EB VCA STAT M TEST KIT
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