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510(k) Data Aggregation
K Number
K082763Device Name
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
Manufacturer
Date Cleared
2008-11-12
(51 days)
Product Code
Regulation Number
862.1665Why did this record match?
Product Code :
MZU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Device Description
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K Number
K042189Device Name
DIAZYME SODIUM ENZYMATIC ASSAY
Manufacturer
Date Cleared
2004-10-07
(56 days)
Regulation Number
862.1665Why did this record match?
Product Code :
MZU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low and High Calibrators, are intended for the quantitative determination of sodium (NA) in serum.
Device Description
Diazyme's Sodium Enzymatic assay is proven to be equivalent to ISE method but more user friendly in automated analyzers. Sodium is determined enzymatically via sodium dependent ß-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.
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