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510(k) Data Aggregation
K Number
K984119Device Name
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
1999-01-15
(58 days)
Product Code
CFM
Regulation Number
862.1410Why did this record match?
Product Code :
CFM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis, and chronic renal disease.
Device Description
The Wako L-type Fe test is an in vitro diagnostic assay for the quantitative determination of iron in serum. When a sample is mixed with the Buffer, serum protein is denatured by the action of surfactant contained in the Buffer and transferrin-bound iron is liberated. All the Fe" ions released are reduced to Fe2+ by L-ascorbate and form a chelate with bathophenanthroline disulfonic acid disodium salt. The serum iron can be determined by measuring the absorbance of the red chelate solution.
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K Number
K981581Device Name
IRON
Manufacturer
ABBOTT LABORATORIES
Date Cleared
1998-06-08
(35 days)
Product Code
CFM
Regulation Number
862.1410Why did this record match?
Product Code :
CFM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
Device Description
Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.
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