510(k) K253069— Lipoprotein (a) Molarity Assay

Substantially Equivalent

Diazyme Laboratories, Inc.

Clearance details

Applicant: Diazyme Laboratories, Inc.
Product code: Code DFC
Advisory panel: Immunology
Date received: 2025-09-23
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.