K253358

Substantially Equivalent

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

Applicant: Diazyme Laboratories, Inc.
Product code: DFH
Advisory panel: Immunology
Date received: 2025-09-30
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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