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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name next generation sequencing based tumor profiling test
510(k) Number K190661
Device Name Omics Core
Applicant
NantHealth, Inc.
9920 Jefferson Blvd
culver city,  CA  90232
Applicant Contact aleece nolasco
Correspondent
NantHealth, Inc.
9920 Jefferson Blvd
culver city,  CA  90232
Correspondent Contact aleece nolasco
Regulation Number866.6080
Classification Product Code
PZM  
Date Received03/14/2019
Decision Date 11/09/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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