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

    CYTOSCAN(R) DX

    K Number: DEN130018 · Decision Jan 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    CYTOSCAN(R) DX
    K Number
    DEN130018
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.5920
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Affymetrix, Inc.
    Date Received
    December 18, 2013
    Decision Date
    January 17, 2014
    Product Code
    PFX
    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
    PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

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    Other Clearances by Affymetrix, Inc.

    K Number Device Name
    K103112 AFFYMETRIX GENE PROFILING REAGENTS
    K080995 MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
    DEN040012 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM