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510(k) Data Aggregation

    K Number
    K983517
    Device Name
    SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
    Manufacturer
    Date Cleared
    1998-11-12

    (36 days)

    Product Code
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAM SCIENTIFIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic testing.
    Device Description
    The SAFE-T-FILL® Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. It is a non-invasive device. SAFE-T-FILL® is a 100 % plastic preassembled system made up of 4 components. A capillary end-to-end tube, a colored sleeve which holds the capillary, a microtube, and a cap. The sleeve and cap come in different colors which identify the general type of additive or anticoagulant that is contained within the microtube. Blood is collected into the capillary tube and allowed to flow into the microtube. The tube is capped, mixed and then processed by the user organization.
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    K Number
    K981973
    Device Name
    SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
    Manufacturer
    Date Cleared
    1998-09-03

    (90 days)

    Product Code
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAM SCIENTIFIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for testing. The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic hematology testing.
    Device Description
    The SAFE-T-FILL® Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. It is a non-invasive device. SAFE-T-FILL® is a 100 % plastic preassembled system made up of 4 components. A capillary end-to-end tube, a colored sleeve which holds the capillary, a microtube, and a cap. The sleeve and cap come in anticoagulant that is contained within the microtube. Blood is collected into the capillary tube and allowed to flow into the microtube. The tube is capped, mixed and then processed by the user organization.
    Ask a Question

    Ask a specific question about this device

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