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

    BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)

    K Number: K013148 · Decision Feb 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    11
    Applicant Total
    12
    Review Days
    161

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    Basic Information

    Device Name
    BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
    K Number
    K013148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biogenex Laboratories
    Date Received
    September 20, 2001
    Decision Date
    February 28, 2002
    Product Code
    MYA
    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
    MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

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