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510(k) Data Aggregation

    K Number
    K203562
    Device Name
    Finetest Lite Blood Glucose Monitoring System
    Date Cleared
    2021-07-13

    (218 days)

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

    Osang Healthcare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Finetest Lite Blood Glucose Monitoring System is comprised of Finetest Lite Blood Glucose meter and Finetest Lite Blood Glucose Testing Strips. It is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, calf and thigh. The Finetest Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Finetest Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
    Device Description
    The proposed Finetest Lite Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
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    K Number
    K201396
    Device Name
    Finetest Lite Smart Blood Glucose Monitoring System
    Date Cleared
    2020-10-16

    (141 days)

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

    OSANG Healthcare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Finetest lite Smart Blood Glucose Monitoring System is comprised of the Smart meter and the Finetest Lite Smart Blood Glucose Test Strips. The Finetest Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Finetest Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Finetest Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The Finetest Lite Smart Blood Glucose Test Strips are for use with the Finetest Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be fingertins, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
    Device Description
    The Finetest Lite Smart Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
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    K Number
    K182286
    Device Name
    Oh'Care Lite Smart Blood Glucose Monitoring System
    Date Cleared
    2018-09-19

    (27 days)

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

    OSANG Healthcare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Oh'Care Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The Oh'Care Lite Smart Blood Glucose Test Strips are for use with the Oh'Care Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
    Device Description
    The proposed Oh'Care Lite Smart Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
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