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510(k) Data Aggregation

    K Number
    K010039
    Device Name
    QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
    Manufacturer
    CHRONIMED, INC.
    Date Cleared
    2001-08-10

    (217 days)

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

    CHRONIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983432
    Device Name
    SUPREME II CONTROL SOLUTIONS
    Manufacturer
    CHRONIMED, INC.
    Date Cleared
    1998-12-17

    (79 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRONIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Supreme II Control Solutions is to verify the performance of the Supreme II Blood Glucose Test System using solutions with a known amount of glucose. The solutions are intended for in-vitro use only.
    Device Description
    Supreme II Control Solutions
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    K Number
    K980573
    Device Name
    SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CHRONIMED, INC.
    Date Cleared
    1998-07-30

    (163 days)

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

    CHRONIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The quantitative determination of glucose in whole blood.
    Device Description
    Blood Glucose Monitoring System ( Meter, Test Strips, Control Solutions )
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    K Number
    K981555
    Device Name
    DIASCREEN REAGENT STRIPS
    Manufacturer
    CHRONIMED, INC.
    Date Cleared
    1998-06-01

    (31 days)

    Product Code
    LJX
    Regulation Number
    864.7675
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRONIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
    Device Description
    DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen. The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
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    K Number
    K963544
    Device Name
    SUPREME II METER
    Manufacturer
    CHRONIMED, INC.
    Date Cleared
    1997-02-20

    (169 days)

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

    CHRONIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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