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

    CYANMETHEMOGLOBIN STANDARD

    K Number: K871283 · Decision Apr 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    22
    Review Days
    15

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    Basic Information

    Device Name
    CYANMETHEMOGLOBIN STANDARD
    K Number
    K871283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8165
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    U. S. Diagnostics, Inc.
    Date Received
    March 31, 1987
    Decision Date
    April 15, 1987
    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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