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

    ILLUMINA MISEQDX PLATFORM

    K Number: DEN130011 · Decision Nov 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    57

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ILLUMINA MISEQDX PLATFORM
    K Number
    DEN130011
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.2265
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Illumina, Inc.
    Date Received
    September 23, 2013
    Decision Date
    November 19, 2013
    Product Code
    PFF
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PFF High Throughput Dna Sequence Analyzer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PFF), ordered by most recent decision date.

    Ion PGM Dx System

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Illumina, Inc.

    K Number Device Name
    K132750 ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
    DEN130042 MISEQDX UNIVERSAL KIT 1.0
    K124006 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
    K093129 ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
    K093128 ILLUMINA BEADXPRESS SYSTEM