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

    HGB-CAL SET/MULTIPLE

    K Number: K893984 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    79
    Review Days
    71

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    Basic Information

    Device Name
    HGB-CAL SET/MULTIPLE
    K Number
    K893984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8165
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    R&D Systems, Inc.
    Date Received
    June 5, 1989
    Decision Date
    August 15, 1989
    Product Code
    KRZ
    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
    KRZ Calibrator For Hemoglobin And Hematocrit Measurement

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