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

    BIOTRACK HEMOGLOBIN TEST CARTRIDGE

    K Number: K895101 · Decision Oct 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    16
    Review Days
    56

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    Basic Information

    Device Name
    BIOTRACK HEMOGLOBIN TEST CARTRIDGE
    K Number
    K895101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Biotrack, Inc.
    Date Received
    August 15, 1989
    Decision Date
    October 10, 1989
    Product Code
    KHG
    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
    KHG Whole Blood Hemoglobin Determination

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