FDA 510(k)

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

N.º K: K223597 · 2023-08-31

Fecha de decisión2023-08-31

Código de productoQAZ

Comité asesorMG

DecisiónSubstantially Equivalent

Resumen del dispositivo

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is the device name listed in this FDA 510(k) record. The listed applicant is 23AndMe, Inc.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K223597. The device is classified under product code QAZ. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)?

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is 23AndMe, Inc.. The 510(k) number is K223597.

When did 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) receive FDA 510(k) clearance?

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) received FDA 510(k) clearance on 2023-08-31, under 510(k) number K223597.

Who is the listed applicant for 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)?

The FDA 510(k) record lists 23AndMe, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)?

The FDA product code for 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is QAZ.

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Otros registros que enlistan a 23AndMe, Inc. como solicitante

K22188523andMe Personal Genome Service (PGS) Pharmacogenetic Reports K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)K19349223andMe Personal Genome Service (PGS) Pharmacogenetic Reports K182784MUTYH-Associated Polyposis (MAP)

Dispositivos relacionados (Código: QAZ)

K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)23AndMe, Inc.K182784MUTYH-Associated Polyposis (MAP)23AndMe, Inc.

Fuente oficial

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