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

    CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

    K Number: K091766 · Decision Feb 24, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    9
    Applicant Total
    30
    Review Days
    252

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    Basic Information

    Device Name
    CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
    K Number
    K091766
    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
    June 17, 2009
    Decision Date
    February 24, 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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