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FDA 510(k) Applications Submitted by Marianna Frendo
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211499
05/14/2021
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
23andMe, Inc.
K221885
06/29/2022
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
23andMe, Inc.
K223597
12/02/2022
23andMe« Personal Genome Service« (PGS«) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
23andMe, Inc.
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