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

    INPLEX CF MOLECULAR TEST

    K Number: K063787 · Decision Mar 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    448

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    Basic Information

    Device Name
    INPLEX CF MOLECULAR TEST
    K Number
    K063787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5900
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Third Wave Technologies, Inc.
    Date Received
    December 21, 2006
    Decision Date
    March 13, 2008
    Product Code
    NUA
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

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    Other Clearances by Third Wave Technologies, Inc.

    K Number Device Name
    K051824 INVADER UGT1A1 MOLECULAR ASSAY