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

    Biocode Gastrointestinal Pathogen Panel (GPP)

    K Number: K190585 · Decision Jun 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    37
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    Biocode Gastrointestinal Pathogen Panel (GPP)
    K Number
    K190585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied BioCode, Inc.
    Date Received
    March 6, 2019
    Decision Date
    June 5, 2019
    Product Code
    PCH
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

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    Other Clearances by Applied BioCode, Inc.

    K Number Device Name
    K254139 BioCode® Respiratory Pathogen Panel (RPP)
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    K192485 BioCode Respiratory Pathogen Panel (RPP)
    K180041 BioCode Gastrointestinal Pathogen Panel (GPP)