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

    BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR

    K Number: K012960 · Decision Mar 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    12
    Review Days
    185

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    Basic Information

    Device Name
    BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
    K Number
    K012960
    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 4, 2001
    Decision Date
    March 8, 2002
    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

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    Other Clearances by Biogenex Laboratories

    K Number Device Name
    K013148 BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
    K925189 PREGNAGEN 1-STEP PREGNANCY TEST
    K902208 MODIFIED OVUGEN
    K884880 PREGNAGEN(TM)
    K882002 PREGNAGEN(TM)
    K873534 OVUGEN SURETEST
    K831221 RIAGEN B-HCG RIA KIT
    K821657 RIAGEN B-HCG RIA
    K821234 RIAGEN B-HCG RIA
    K820724 FLUOROGEN PAP FIA
    Search all 12 clearances from Biogenex Laboratories →