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

    BioCode Gastrointestinal Pathogen Panel (GPP)

    K Number: K180041 · Decision Sep 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    37
    Applicant Total
    5
    Review Days
    266

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BioCode Gastrointestinal Pathogen Panel (GPP)
    K Number
    K180041
    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
    January 5, 2018
    Decision Date
    September 28, 2018
    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

    Similar 510(k) Clearances

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

    LIAISON PLEX Gastrointestinal Flex Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Xpert GI Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Panther Fusion GI Expanded Bacterial Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Panther Fusion GI Bacterial Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Applied BioCode, Inc.

    K Number Device Name
    K254139 BioCode® Respiratory Pathogen Panel (RPP)
    K242877 BioCode Gastrointestinal Pathogen Panel (GPP)
    K192485 BioCode Respiratory Pathogen Panel (RPP)
    K190585 Biocode Gastrointestinal Pathogen Panel (GPP)