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

Name: FDA 510(k) clearance K253069
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Substantially Equivalent

Diazyme Laboratories, Inc.

FDA 510(k) clearance K253069 for Lipoprotein (a) Molarity Assay, Substantially Equivalent on 2026-06-16. Applicant: Diazyme Laboratories, Inc.. Device class: 2.

Summary

Diazyme Laboratories' Lipoprotein (a) Molarity Assay is filed under DFC, low-density lipoprotein antigens, antisera, and controls. The record doesn't describe the assay beyond its name and the code name.

Class II, 21 CFR 866.5600. The Clinical Chemistry review panel handled it as a Traditional 510(k), though the record lists Immunology as the classification panel.

Diazyme filed from Poway, California. Review took 266 calendar days (September 23, 2025 to June 16, 2026).

Clearance details

Applicant: Diazyme Laboratories, Inc.
Product code: Product code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2025-09-23
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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

Summary

Clearance details

Recent devices under product code DFC

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