BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).

    K Number: K193393 · Decision Mar 6, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    3
    Review Days
    91

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    Basic Information

    Device Name
    BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
    K Number
    K193393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leica Biosystems Newcastle, Ltd.
    Date Received
    December 6, 2019
    Decision Date
    March 6, 2020
    Product Code
    MXZ
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

    Similar 510(k) Clearances

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    Other Clearances by Leica Biosystems Newcastle, Ltd.

    K Number Device Name
    K213348 BOND MMR Antibody Panel
    K122556 VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)