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

    TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS

    K Number: K030703 · Decision Jul 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    22
    Review Days
    127

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    Basic Information

    Device Name
    TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
    K Number
    K030703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Home Diagnostics, Inc.
    Date Received
    March 6, 2003
    Decision Date
    July 11, 2003
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by Home Diagnostics, Inc.

    K Number Device Name
    K090495 TRUEBALANCE BLOOD GLUCOSE SYSTEM
    K080641 TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
    K080710 TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
    K070593 TRACKRECORD DATA MANAGEMENT SOFTWARE
    K060793 ELEMENT BLOOD GLUCOSE TEST SYSTEM
    K051147 SIDEKICK BLOOD GLUCOSE TEST SYSTEM
    K042080 TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
    K040670 MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
    K032657 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
    K010403 PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
    Search all 22 clearances from Home Diagnostics, Inc. →