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

    MAGO 4S

    K Number: K093101 · Decision Jan 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    93
    Applicant Total
    68
    Review Days
    477

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    Basic Information

    Device Name
    MAGO 4S
    K Number
    K093101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diamedix Corp.
    Date Received
    October 1, 2009
    Decision Date
    January 21, 2011
    Product Code
    LFX
    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
    LFX Enzyme Linked Immunoabsorbent Assay, Rubella

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