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

    HEMOCUE B-HEMOGLOBIN SYSTEM

    K Number: K961312 · Decision Sep 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    9
    Review Days
    173

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    Basic Information

    Device Name
    HEMOCUE B-HEMOGLOBIN SYSTEM
    K Number
    K961312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hemocue, Inc.
    Date Received
    April 4, 1996
    Decision Date
    September 24, 1996
    Product Code
    GKR
    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
    GKR System, Hemoglobin, Automated

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    Other Clearances by Hemocue, Inc.

    K Number Device Name
    K041234 HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
    K041230 CLINICAL LABORATORY ANALYZING SYSTEM
    K032203 HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
    K020935 HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
    K962415 HEMOCUE B-GLCOSE SYSTEM
    K961311 HEMOCUE B-GLUCOSE SYSTEM
    K943432 HEMOCUE B-GLUCOSE SYSTEM
    K911141 HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER