FDA 510(k)

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

K-번호: K221885 · 2022-10-26

결정일2022-10-26

제품 코드QDJ

자문 위원회[기업명]의 [제품명]은 미국 식품의약국(FDA)에서 510(k) 신청을 통해 승인받은 의료기기입니다. 이 제품은 [PMA] 신청을 통해 추가적인 승인을 받았으며, 연구를 위한 [NCT] 번호는 [PMID] 번호는 [identifier]입니다. 보다 자세한 정보는 다음 URL을 참조하세요: [URL].

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기기 요약

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is the device name listed in this FDA 510(k) record. The listed applicant is 23AndMe, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K221885. The device is classified under product code QDJ. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports?

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is 23AndMe, Inc.. The 510(k) number is K221885.

When did 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports receive FDA 510(k) clearance?

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports received FDA 510(k) clearance on 2022-10-26, under 510(k) number K221885.

Who is the listed applicant for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports?

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) Pharmacogenetic Reports?

The FDA product code for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is QDJ.

23AndMe, Inc.를 신청인으로 등재한 기타 기록

K22359723andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)K19349223andMe Personal Genome Service (PGS) Pharmacogenetic Reports K182784MUTYH-관련 다발성 종양증 (MAP)

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