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