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

    BINAXNOW PBP2A TEST, MODEL 890-000

    K Number: K090301 · Decision Apr 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    9
    Applicant Total
    30
    Review Days
    432

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    Basic Information

    Device Name
    BINAXNOW PBP2A TEST, MODEL 890-000
    K Number
    K090301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Binax, Inc.
    Date Received
    February 6, 2009
    Decision Date
    April 14, 2010
    Product Code
    MYI
    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
    MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

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    Other Clearances by Binax, Inc.

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