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

    TRANSTAT-CMV(TM)

    K Number: K903308 · Decision Dec 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    93
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    TRANSTAT-CMV(TM)
    K Number
    K903308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ab Sangtec Medical
    Date Received
    July 24, 1990
    Decision Date
    December 4, 1990
    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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