FDA 510(k)

23andMe PGS Relatório de Risco Genético para Câncer de Próstata Hereditário (Relacionado a HOXB13)

Número K: K211499 · 2022-01-06

Data da decisão2022-01-06

Código do produtoQAZ

Comité consultivoMG

DecisãoSubstantially Equivalent

Resumo do dispositivo

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is the device name listed in this FDA 510(k) record. The listed applicant is 23AndMe, Inc.. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K211499. The device is classified under product code QAZ. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is 23AndMe, Inc.. The 510(k) number is K211499.

When did 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) receive FDA 510(k) clearance?

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) received FDA 510(k) clearance on 2022-01-06, under 510(k) number K211499.

Who is the listed applicant for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

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 PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

The FDA product code for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is QAZ.

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Outros registros que listam 23AndMe, Inc. como candidato(a)

K22359723andMe® Serviço de Genômica Pessoal® (PGS®) Relatório de Risco Genético de Saúde para BRCA1/BRCA2 (Variantes Selecionadas)K22188523andMe Serviço de Genômica Pessoal (PGS) Relatórios Farmacogenéticos K19349223andMe Serviço de Genômica Pessoal (PGS) Relatórios Farmacogenéticos K182784MUTYH-Associated Polyposis (MAP)

Dispositivos Relacionados (Código: QAZ)

K22359723andMe® Serviço de Genômica Pessoal® (PGS®) Relatório de Risco Genético de Saúde para BRCA1/BRCA2 (Variantes Selecionadas)23AndMe, Inc.K182784MUTYH-Associated Polyposis (MAP)23AndMe, Inc.

Fonte oficial

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