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510(k) Data Aggregation

    K Number
    K002867
    Device Name
    INVERNESS MEDICAL OVULATION PREDICTOR TEST
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    2000-10-12

    (29 days)

    Product Code
    CEP
    Regulation Number
    862.1485
    Why did this record match?
    Applicant Name (Manufacturer) :

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002134
    Device Name
    ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    2000-08-07

    (24 days)

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

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002049
    Device Name
    INVERNESS MEDICAL EARLY PREGNANCY TEST
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    2000-07-27

    (24 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001427
    Device Name
    MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    2000-06-02

    (28 days)

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

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000583
    Device Name
    FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    2000-03-17

    (24 days)

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

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993632
    Device Name
    FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1999-11-12

    (16 days)

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

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FastTake® Compact Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The FastTake® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.
    Device Description
    The FastTake® system includes four main components: - FastTake® Test Strips . - FastTake® Compact Blood Glucose Meter - FastTake® Control Solution - Penlet II or Penlet Plus lancing device and FinePoint lancets.
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    K Number
    K991480
    Device Name
    EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1999-09-17

    (142 days)

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

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use . by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.
    Device Description
    Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.
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    K Number
    K991386
    Device Name
    EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1999-05-25

    (34 days)

    Product Code
    CEP
    Regulation Number
    862.1485
    Why did this record match?
    Applicant Name (Manufacturer) :

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor.
    Device Description
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor. The technological characteristics are the same because both devices are One-step urine tests that measure LH immunochromatographically, and have the same safety and effectiveness.
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    K Number
    K991466
    Device Name
    EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1999-05-25

    (28 days)

    Product Code
    CEP
    Regulation Number
    862.1485
    Why did this record match?
    Applicant Name (Manufacturer) :

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.
    Device Description
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.
    Ask a Question
    K Number
    K990939
    Device Name
    FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1999-04-20

    (29 days)

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

    SELFCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FastTake® Compact Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The FastTake® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.
    Device Description
    The FastTake® system includes four main components: - · FastTake® Test Strips - FastTake® Compact Blood Glucose Meter . - · FastTake® Control Solution - · Penlet II or Penlet Plus lancing device and FinePoint lancets.
    Ask a Question

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