510(k) K211648— Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Substantially Equivalent

Diazyme Laboratories, Inc.

Clearance details

Applicant: Diazyme Laboratories, Inc.
Product code: Code DFH
Advisory panel: Immunology
Date received: 2021-05-28
Decision date: 2022-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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