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

    BGM GALECTIN -3

    K Number: K093758 · Decision Nov 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    345

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    Basic Information

    Device Name
    BGM GALECTIN -3
    K Number
    K093758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1117
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bg Medicine, Inc.
    Date Received
    December 7, 2009
    Decision Date
    November 17, 2010
    Product Code
    OSX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OSX Galectin-3 In Vitro Diagnostic Assay

    Similar 510(k) Clearances

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