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

    RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

    K Number: K052716 · Decision Nov 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    90
    Applicant Total
    6
    Review Days
    413

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    Basic Information

    Device Name
    RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
    K Number
    K052716
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Otsuka Pharmaceutical Co., Ltd.
    Date Received
    September 29, 2005
    Decision Date
    November 16, 2006
    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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