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510(k) Data Aggregation

    K Number
    K160922
    Device Name
    FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
    Manufacturer
    Dako North America, Inc.
    Date Cleared
    2016-05-03

    (29 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dako North America, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use. FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVision FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link), is intended for use in immunohistochemistry together with EnVision FLEX+, High pH visualization kit together with Autostainer Link 48 instrument to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded human breast carcinoma. This antibody labels progesterone receptor-positive cells and is useful in the assessment of progesterone receptor status in human breast carcinomas. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
    Device Description
    Not Found
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    K Number
    K130861
    Device Name
    MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Date Cleared
    2013-12-09

    (256 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAKO NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (LINK) is intended for use in immunohistochemistry with EnVision™ FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma. This antibody labels progesterone receptor positive cells and is useful in the assessment of progesterone receptor status in human breast carcinomas. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
    Device Description
    Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) antibody is utilized to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma. This product is pre-diluted and optimized for use with the Dako Autostainer Link 48 automated slide staining platform. Anti-PR, Clone PgR 636 is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The target concentration of Anti-PR, Clone PgR 636 is 0.5 ug/mL; the acceptable concentration range is 0.4 ug/mL to 0.6 ug/mL.
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    K Number
    K120663
    Device Name
    MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Date Cleared
    2013-02-12

    (344 days)

    Product Code
    MYA, IR0
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAKO NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use. FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
    Device Description
    Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.
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    K Number
    K081286
    Device Name
    MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Date Cleared
    2009-05-08

    (366 days)

    Product Code
    MYA
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAKO NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use. Monoclonal Rabbit Anti-Human Estrogen Receptor a (ER a) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients. Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
    Device Description
    Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1 is a semiquantitative immunohistochemical (IHC) kit assay to identify estrogen receptor (ER) expression in normal and neoplastic tissues routinely processed and paraffin-embedded.
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