Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay— 510(k) K253358

Name: FDA 510(k) clearance K253358
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Substantially Equivalent

Diazyme Laboratories, Inc.

FDA 510(k) clearance K253358 for Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay, Substantially Equivalent on 2025-12-19. Applicant: Diazyme Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories, Inc.
Product code: Code DFH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 2025-09-30
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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