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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