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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kappa, Antigen, Antiserum, Control
510(k) Number K153394
Device Name 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
Applicant
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received11/24/2015
Decision Date 11/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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