DeviceClearance

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay— 510(k) K220001

Substantially Equivalent

Diazyme Laboratories, Inc.

FDA 510(k) clearance K220001 for Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Substantially Equivalent on 2022-08-04. Applicant: Diazyme Laboratories, Inc..

Clearance details

Applicant
Diazyme Laboratories, Inc.
Product code
Code DFH
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Poway, CA, US
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