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

    ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER

    K Number: K780946 · Decision Jul 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    22
    Review Days
    48

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    Basic Information

    Device Name
    ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
    K Number
    K780946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5300
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hycel, Inc.
    Date Received
    June 9, 1978
    Decision Date
    July 27, 1978
    Product Code
    JPJ
    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
    JPJ Red-Cell Indices, Calculated

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