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510(k) Data Aggregation
K Number
K983517Device Name
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Manufacturer
Date Cleared
1998-11-12
(36 days)
Product Code
Regulation Number
862.1675Why 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
K981973Device Name
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Manufacturer
Date Cleared
1998-09-03
(90 days)
Product Code
Regulation Number
862.1675Why 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.
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Ask a specific question about this device
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