Diazyme Laboratories, Inc. Announces FDA 510(k) Clearance for Lipoprotein(a) Molarity Assay
17th Jun 2026
POWAY, CA – June 17, 2026 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Diazyme Lipoprotein(a) Molarity Assay. This clearance enables clinical laboratories to use the assay for the quantitative determination of lipoprotein-Lp(a) levels in human serum and plasma, reported in molar units (nmol/L).
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