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

    ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

    K Number: K132750 · Decision Nov 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    77

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    Basic Information

    Device Name
    ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
    K Number
    K132750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5900
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Illumina, Inc.
    Date Received
    September 3, 2013
    Decision Date
    November 19, 2013
    Product Code
    PFS
    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
    PFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

    Other Clearances by Illumina, Inc.

    K Number Device Name
    DEN130042 MISEQDX UNIVERSAL KIT 1.0
    K124006 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
    DEN130011 ILLUMINA MISEQDX PLATFORM
    K093129 ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
    K093128 ILLUMINA BEADXPRESS SYSTEM