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510(k) Data Aggregation
K Number
K060617Device Name
PTS PANELS HDL CHOLESTEROL TEST STRIPS
Manufacturer
POLYMER TECHNOLOGY SYSTEMS, INC.
Date Cleared
2006-04-05
(28 days)
Product Code
NAQ, LBR
Regulation Number
862.1175Why did this record match?
Product Code :
NAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PTS PANELS HDL Cholesterol Test Strips are intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Device Description
PTS PANELS HDL Cholesterol Test Strips consist of chemical reagents in dry form. When whole blood is placed on the test strip, only the HDL cholesterol fraction passes through to the reaction layer. The HDL cholesterol reacts with a dried cholesterol reagent to produce color. The HDL concentration is proportional to the intensity of the color developed and is measured by a CardioChek brand analyzer.
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K Number
K993377Device Name
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
Manufacturer
POLYMER TECHNOLOGY SYSTEMS, INC.
Date Cleared
2000-01-13
(107 days)
Product Code
NAQ
Regulation Number
862.1175Why did this record match?
Product Code :
NAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the BioScanner. This system is intended to be used to assist the healthcare professional and individuals in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.
Device Description
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