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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 K192063
Device Name PGDx elio tissue complete
Applicant
Personal Genome Diagnostics
2809 Boston Street, Suite 503
Baltimore,  MD  21224
Applicant Contact Jennifer Dickey
Correspondent
Personal Genome Diagnostics
2809 Boston Street, Suite 503
Baltimore,  MD  21224
Correspondent Contact Jennifer Dickey
Regulation Number866.6080
Classification Product Code
PZM  
Date Received08/01/2019
Decision Date 04/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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