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510(k) Data Aggregation

    K Number
    K052469
    Device Name
    GLUCOPACK
    Manufacturer
    HEALTHPIA AMERICA CORP.
    Date Cleared
    2006-06-05

    (270 days)

    Product Code
    NBW, CGA
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHPIA AMERICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlucoPack™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. GlucoPack™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertips only. The GlucoPack Diabetes Monitoring System is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.
    Device Description
    The GlucoPack™ Meter device is used along with the GlucoPack™ Test Strip to measure the glucose level in whole blood.
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