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

    BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

    K Number: DEN070006 · Decision Jun 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    82

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    Basic Information

    Device Name
    BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
    K Number
    DEN070006
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.3402
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Inverness Medical Professional Diagnostics-Binax
    Date Received
    March 23, 2007
    Decision Date
    June 13, 2007
    Product Code
    OAX
    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
    OAX Plasmodium Spp. Detection Reagents