Diazyme Laboratories, Inc. Announces FDA 510(k) Clearance for Lipoprotein(a) Molarity Assay
POWAY, Calif., June 18, 2026 (GLOBE NEWSWIRE) -- Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Di...
News Desk
Staff Writer
Published
Jun 19, 2026
Source
The Manila Times
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AI Insight:This clearance marks a significant step forward in the diagnosis and management of cardiovascular disease.
Diazyme Laboratories, Inc. has secured FDA 510(k) clearance for its Lipoprotein(a) Molarity Assay, a crucial development in the field of cardiovascular diagnostics. The assay is designed to measure lipoprotein(a), a known risk factor for cardiovascular disease, which can lead to conditions such as atherosclerosis, heart attacks, and strokes. The FDA clearance enables Diazyme Laboratories to market and distribute the assay, making it available to healthcare professionals for use in clinical settings. This development is expected to improve the accuracy and efficiency of cardiovascular disease diagnosis and management, ultimately contributing to better patient outcomes. The Lipoprotein(a) Molarity Assay is a significant addition to Diazyme Laboratories' portfolio of diagnostic solutions, solidifying its position as a leading provider of innovative laboratory testing products.