Diazyme Laboratories, Inc. Announces FDA 510(k) Clearance for Lipoprotein(a) Molarity Assay
Diazyme Laboratories, Inc. has received FDA 510(k) clearance for their Lipoprotein(a) Molarity Assay, allowing clinical labs to measure lipoprotein-Lp(a) levels in human serum and plasma in molar units. This assay aims to provide an isoform-independent measurement, enhancing cardiovascular risk assessment and supporting clinicians in identifying high-risk patients.
Diazyme receives FDA 510(k) clearance for its isoform‑independent Lipoprotein(a) Molarity Assay, improving standardized cardiovascular risk assessment.