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

    AFFYMETRIX GENE PROFILING REAGENTS

    K Number: K103112 · Decision May 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    195

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    Basic Information

    Device Name
    AFFYMETRIX GENE PROFILING REAGENTS
    K Number
    K103112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.2570
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Affymetrix, Inc.
    Date Received
    October 21, 2010
    Decision Date
    May 4, 2011
    Product Code
    OVA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OVA Complete Gene Expression Profiling Accessory Reagents

    Other Clearances by Affymetrix, Inc.

    K Number Device Name
    DEN130018 CYTOSCAN(R) DX
    K080995 MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
    DEN040012 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM