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Small, dense LDL assay cleared, 11/17

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November 2017—Denka Seiken has received FDA 510(k) clearance for its small, dense LDL cholesterol (sdLDL-C) assay, designed for use with automated chemistry analyzers. The assay is an in vitro diagnostic reagent for the measurement of coronary heart disease risk marker sdLDL-C and can quantify sdLDL-C in serum and plasma samples in 10 minutes.

Denka Seiken, 408-371-8819

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