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

    QTEST INFLUENZA A

    K Number: K913828 · Decision Sep 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    632
    Review Days
    28

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    Basic Information

    Device Name
    QTEST INFLUENZA A
    K Number
    K913828
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    August 26, 1991
    Decision Date
    September 23, 1991
    Product Code
    GNT
    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
    GNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C

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