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510(k) Data Aggregation
K Number
K180074Device Name
Diazyme Lipoprotein (a) Assay
Manufacturer
Diazyme Laboratories, Inc.
Date Cleared
2018-03-22
(71 days)
Product Code
DFC
Regulation Number
866.5600Why did this record match?
Applicant Name (Manufacturer) :
Diazyme Laboratories, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or Clinical Chemistry Systems. The measurement of Lipoprotein (a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only.
Device Description
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