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

    JBAIDS INFLUENZA A SUBTYPING KIT

    K Number: K111778 · Decision Sep 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    JBAIDS INFLUENZA A SUBTYPING KIT
    K Number
    K111778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3332
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U.S Army Medical Materiel Development Activity
    Date Received
    June 23, 2011
    Decision Date
    September 13, 2011
    Product Code
    OQW
    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
    OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

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    Other Clearances by U.S Army Medical Materiel Development Activity

    K Number Device Name
    K152523 JBAIDS Influenza A & B Detection Kit