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

    PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

    K Number: K080896 · Decision Jul 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
    K Number
    K080896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Pathwork Diagnostics, Inc.
    Date Received
    March 31, 2008
    Decision Date
    July 30, 2008
    Product Code
    OIW
    Advisory Committee
    Clinical Toxicology
    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
    OIW Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

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    Other Clearances by Pathwork Diagnostics, Inc.

    K Number Device Name
    K120489 TISSUE OF ORIGIN TEST KIT FFPE