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

    TISSUE OF ORIGIN TEST KIT FFPE

    K Number: K120489 · Decision May 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    TISSUE OF ORIGIN TEST KIT FFPE
    K Number
    K120489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pathwork Diagnostics, Inc.
    Date Received
    February 17, 2012
    Decision Date
    May 17, 2012
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OIW), ordered by most recent decision date.

    Tissue of Origin Test Kit-FFPE

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    PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE

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    FDA Class 2 ·Clinical Toxicology

    PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

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    Other Clearances by Pathwork Diagnostics, Inc.

    K Number Device Name
    K080896 PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST