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

    PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST

    K Number: K861974 · Decision Aug 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
    K Number
    K861974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Perceptive Systems, Inc.
    Date Received
    May 21, 1986
    Decision Date
    August 4, 1986
    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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    Other Clearances by Perceptive Systems, Inc.

    K Number Device Name
    K952778 CHESHIRE