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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name human leukocyte antigen (hla) typing companion diagnostic test
De Novo Number BR220737
Device Name SeCore CDx HLA Sequencing System
Product CodeQUK
Device ClassII
Regulation Number866.5960
Submission Type Direct De Novo
Requestor
One Lambda, Inc.
22801 roscoe blvd
west hills,  CA  91304
Date Received07/01/2022
Decision Date 11/28/2022
DecisionGranted - Direct De Novo
Expedited Review No
Third Party Review Not Third Party Elligble
In Vitro Device? No
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