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510(k) Data Aggregation

    K Number
    K002688
    Device Name
    PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
    Manufacturer
    LXN CORP.
    Date Cleared
    2001-02-01

    (156 days)

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

    LXN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991754
    Device Name
    GO GLUCOSE MONITORING SYSTEM
    Manufacturer
    LXN CORP.
    Date Cleared
    1999-09-08

    (107 days)

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

    LXN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GO Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose in whole blood specimens. The GO Glucose Monitoring System is intended for use by people with diabetes to monitor their blood glucose levels in a home use setting. This in vitro test kit is indicated for home use (over the counter).
    Device Description
    GO Glucose Monitoring System
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    K Number
    K990942
    Device Name
    DUET II GLUCOSE CONTROL MONITORING SYSTEM
    Manufacturer
    LXN CORP.
    Date Cleared
    1999-08-02

    (133 days)

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

    LXN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Duet II Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The Duet II Glucose Monitoring System is to be used by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This is in vitro test kit is intended for home use (over the counter).
    Device Description
    Duet II Glucose Control Monitoring System
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    K Number
    K973140
    Device Name
    DUET GLUCOSE CONTROL MONITORING SYSTEM
    Manufacturer
    LXN CORP.
    Date Cleared
    1997-10-31

    (71 days)

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

    LXN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DUETTM Glucose Control Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The DUET Fructosamine Test System is intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This in vitro test kit is intended for home use (over the counter).
    Device Description
    Not Found
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    K Number
    K962597
    Device Name
    LXN FRUCTOSAMINE TEST SYSTEM
    Manufacturer
    LXN CORP.
    Date Cleared
    1997-06-13

    (346 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    LXN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LXN™ Fructosamine Test System is a device intended to measure fructosamine quantitatively in blood. The LXN™ Fructosamine Test System is intended for use by diabetics to monitor their blood fructosamine levels in a home use setting.
    Device Description
    Not Found
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    K Number
    K960034
    Device Name
    LXN BLOOD GLUCOSE TEST SYSTEM
    Manufacturer
    LXN CORP.
    Date Cleared
    1996-06-28

    (177 days)

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

    LXN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955629
    Device Name
    LXN FRUCTOSAMINE TEST
    Manufacturer
    LXN CORP.
    Date Cleared
    1996-03-20

    (100 days)

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

    LXN CORP.

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

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