DeviceClearance

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator— 510(k) K153394

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K153394 for Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Substantially Equivalent on 2016-11-18. Applicant: Diazyme Laboratories.

Clearance details

Applicant
Diazyme Laboratories
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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