K220001

Substantially Equivalent

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Applicant: Diazyme Laboratories, Inc.
Product code: DFH
Advisory panel: Immunology
Date received: 2022-01-04
Decision date: 2022-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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