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Found 15 results
510(k) Data Aggregation
K Number
K002867Device Name
INVERNESS MEDICAL OVULATION PREDICTOR TEST
Manufacturer
SELFCARE, INC.
Date Cleared
2000-10-12
(29 days)
Product Code
CEP
Regulation Number
862.1485Why did this record match?
Applicant Name (Manufacturer) :
SELFCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002134Device Name
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
SELFCARE, INC.
Date Cleared
2000-08-07
(24 days)
Product Code
CGA
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
SELFCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002049Device Name
INVERNESS MEDICAL EARLY PREGNANCY TEST
Manufacturer
SELFCARE, INC.
Date Cleared
2000-07-27
(24 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
SELFCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001427Device Name
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
SELFCARE, INC.
Date Cleared
2000-06-02
(28 days)
Product Code
CGA
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
SELFCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000583Device Name
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
SELFCARE, INC.
Date Cleared
2000-03-17
(24 days)
Product Code
CGA
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
SELFCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993632Device Name
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
SELFCARE, INC.
Date Cleared
1999-11-12
(16 days)
Product Code
CGA
Regulation Number
862.1345Why 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
K991480Device Name
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
Manufacturer
SELFCARE, INC.
Date Cleared
1999-09-17
(142 days)
Product Code
CGA
Regulation Number
862.1345Why 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
K991386Device 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
862.1485Why 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
K991466Device 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
862.1485Why 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.
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K Number
K990939Device Name
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
SELFCARE, INC.
Date Cleared
1999-04-20
(29 days)
Product Code
CGA
Regulation Number
862.1345Why 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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