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

    NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

    K Number: K101185 · Decision Sep 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    510

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    Basic Information

    Device Name
    NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
    K Number
    K101185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iris Molecular Diagnostics
    Date Received
    April 28, 2010
    Decision Date
    September 20, 2011
    Product Code
    OWM
    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
    OWM Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers