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

Kappa, Antigen, Antiserum, Control

Diazyme Laboratories Inc.

The following data is part of a premarket notification filed by Diazyme Laboratories Inc. with the FDA for Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay.

Pre-market Notification Details

Device IDK211648
510k NumberK211648
Device Name:Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
ClassificationKappa, Antigen, Antiserum, Control
Applicant Diazyme Laboratories Inc. 12889 Gregg Court Poway,  CA  92064
ContactAbhijit Datta
CorrespondentAbhijit Datta
Diazyme Laboratories Inc. 12889 Gregg Court Poway,  CA  92064
Product CodeDFH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-28
Decision Date2022-09-08

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