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

    BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

    K Number: K083744 · Decision Sep 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    2
    Applicant Total
    30
    Review Days
    259

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    Basic Information

    Device Name
    BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
    K Number
    K083744
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Binax, Inc.
    Date Received
    December 16, 2008
    Decision Date
    September 1, 2009
    Product Code
    MJZ
    Advisory Committee
    Clinical Chemistry
    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
    MJZ Kit, Direct Antigen, Positive Control

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