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

    NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS

    K Number: K851508 · Decision Jul 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS
    K Number
    K851508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Nikon, Inc.
    Date Received
    April 15, 1985
    Decision Date
    July 12, 1985
    Product Code
    LNJ
    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
    LNJ Analyzer, Chromosome, Automated

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