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

    HEMOCUE B-GLUCOSE SYSTEM

    K Number: K943432 · Decision Jan 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    186

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    Basic Information

    Device Name
    HEMOCUE B-GLUCOSE SYSTEM
    K Number
    K943432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemocue, Inc.
    Date Received
    July 15, 1994
    Decision Date
    January 17, 1995
    Product Code
    CGA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CGA Glucose Oxidase, Glucose

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    Other Clearances by Hemocue, Inc.

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    K020935 HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
    K962415 HEMOCUE B-GLCOSE SYSTEM
    K961312 HEMOCUE B-HEMOGLOBIN SYSTEM
    K961311 HEMOCUE B-GLUCOSE SYSTEM
    K911141 HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER