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In this section: Substantially Equivalent 510(k) Device Information

BR220737 - SeCore CDx HLA Sequencing System

De Novo Number: BR220737
Applicant: One Lambda Inc.
Device Name: SeCore^TM CDx HLA Sequencing System
Decision Date: 11/28/2022

Supporting Documents:

BR220737 De Novo Classification Order
BR220737 De Novo Decision Summary
BR220737 Package Insert

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