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

    HEMOCUE B-GLUCOSE SYSTEM

    K Number: K961311 · Decision Aug 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    68
    Same Product Code
    72
    Applicant Total
    9
    Review Days
    141

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    Basic Information

    Device Name
    HEMOCUE B-GLUCOSE SYSTEM
    K Number
    K961311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hemocue, Inc.
    Date Received
    April 4, 1996
    Decision Date
    August 23, 1996
    Product Code
    LFR
    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
    LFR Glucose Dehydrogenase, Glucose

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    Other Clearances by Hemocue, Inc.

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    K041234 HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
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    K032203 HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
    K020935 HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
    K962415 HEMOCUE B-GLCOSE SYSTEM
    K961312 HEMOCUE B-HEMOGLOBIN SYSTEM
    K943432 HEMOCUE B-GLUCOSE SYSTEM
    K911141 HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER