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

    MESACUP MODELS BP180 AND BP230 ELISA KITS

    K Number: K071961 · Decision Aug 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    406

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    Basic Information

    Device Name
    MESACUP MODELS BP180 AND BP230 ELISA KITS
    K Number
    K071961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mbl International Corporation
    Date Received
    July 16, 2007
    Decision Date
    August 25, 2008
    Product Code
    OEG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OEG), ordered by most recent decision date.

    EUROIMMUN Anti-BP230-CF ELISA (IgG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    EUROIMMUN ANTI BP 180-4X ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology
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    Other Clearances by Mbl International Corporation

    K Number Device Name
    K060431 ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805