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

    CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

    K Number: K954214 · Decision Jan 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    9
    Review Days
    502

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    Basic Information

    Device Name
    CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
    K Number
    K954214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vysis
    Date Received
    September 7, 1995
    Decision Date
    January 21, 1997
    Product Code
    OXP
    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
    OXP Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

    Other Clearances by Vysis

    K Number Device Name
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    K033982 MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
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    K011031 VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
    K010288 ANEUVYSION MULITICOLOR DNA PROBE KIT
    K972200 ANEUVYSION
    K962873 CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
    K953591 CEP 8 SPECTRUMORANGE DNA PROBE KIT