BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    RIDA GENE Norovirus GI/GII

    K Number: K171511 · Decision Aug 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    RIDA GENE Norovirus GI/GII
    K Number
    K171511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R-Biopharm AG
    Date Received
    May 24, 2017
    Decision Date
    August 21, 2017
    Product Code
    PIQ
    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
    PIQ Reagents For Detection Of Norovirus Nucleic Acid

    Other Clearances by R-Biopharm AG

    K Number Device Name
    DEN110001 RIDASCREEN NOROVIRUS 3RD GENERATION EIA