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

    MICRO21 WITH ANA

    K Number: K960774 · Decision May 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    86

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    Basic Information

    Device Name
    MICRO21 WITH ANA
    K Number
    K960774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Triangle Biomedical Sciences, Inc.
    Date Received
    February 26, 1996
    Decision Date
    May 22, 1996
    Product Code
    JOY
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOY Device, Automated Cell-Locating

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    Other Clearances by Triangle Biomedical Sciences, Inc.

    K Number Device Name
    K982301 MICRO21 WITH URINE SEDIMENT ANALYSIS
    K973050 MICRO21 WITH WBC ESTIMATE
    K971470 MICRO21 WITH CEREBROSPINAL FLUID
    K964165 MICRO21 WITH NDNA
    K960776 MICRO21 WITH RETIC