BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HP-ONE

    K Number: K012411 · Decision Sep 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    90
    Applicant Total
    8
    Review Days
    57

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    Basic Information

    Device Name
    HP-ONE
    K Number
    K012411
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gi Supply
    Date Received
    July 30, 2001
    Decision Date
    September 25, 2001
    Product Code
    LYR
    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
    LYR Helicobacter Pylori

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