FDA 510(k)

23andMe® Serviço de Genômica Pessoal® (PGS®) Relatório de Risco Genético de Saúde para BRCA1/BRCA2 (Variantes Selecionadas)

Número K: K223597 · 2023-08-31

Data da decisão2023-08-31

Código do produtoQAZ

Comité consultivoMG

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K22188523andMe Serviço de Genômica Pessoal (PGS) Relatórios Farmacogenéticos K21149923andMe PGS Relatório de Risco Genético para Câncer de Próstata Hereditário (Relacionado a HOXB13)K19349223andMe Serviço de Genômica Pessoal (PGS) Relatórios Farmacogenéticos K182784MUTYH-Associated Polyposis (MAP)

Dispositivos Relacionados (Código: QAZ)

K21149923andMe PGS Relatório de Risco Genético para Câncer de Próstata Hereditário (Relacionado a HOXB13)23AndMe, Inc.K182784MUTYH-Associated Polyposis (MAP)23AndMe, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.