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

    VYSIS D7S486/CEP 7 FISH PROBE KIT

    K Number: K131508 · Decision Sep 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    17
    Review Days
    112

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    Basic Information

    Device Name
    VYSIS D7S486/CEP 7 FISH PROBE KIT
    K Number
    K131508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1870
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Molecular, Inc.
    Date Received
    May 24, 2013
    Decision Date
    September 13, 2013
    Product Code
    PFG
    Advisory Committee
    Hematology
    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
    PFG Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders

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