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

    GELSCAN, MODEL 1206

    K Number: K100307 · Decision Aug 31, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    27
    Applicant Total
    32
    Review Days
    209

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    Basic Information

    Device Name
    GELSCAN, MODEL 1206
    K Number
    K100307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sebia
    Date Received
    February 3, 2010
    Decision Date
    August 31, 2010
    Product Code
    CFE
    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
    CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

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