FDA 510(k)

Helix 遗傳健康風險應用程式，用於晚發性阿茲海默症

K 號：K192073 · 2020-12-23

決定日期2020-12-23

產品代碼PTA

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

Helix Genetic Health Risk App for late-onset Alzheimer’s disease is the device name listed in this FDA 510(k) record. The listed applicant is Helix Opco, LLC. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K192073. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Helix Genetic Health Risk App for late-onset Alzheimer’s disease?

Helix Genetic Health Risk App for late-onset Alzheimer’s disease is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Helix Opco, LLC. The 510(k) number is K192073.

When did Helix Genetic Health Risk App for late-onset Alzheimer’s disease receive FDA 510(k) clearance?

Helix Genetic Health Risk App for late-onset Alzheimer’s disease received FDA 510(k) clearance on 2020-12-23, under 510(k) number K192073.

Who is the listed applicant for Helix Genetic Health Risk App for late-onset Alzheimer’s disease?

The FDA 510(k) record lists Helix Opco, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helix Genetic Health Risk App for late-onset Alzheimer’s disease?

The FDA product code for Helix Genetic Health Risk App for late-onset Alzheimer’s disease is PTA.

相關器械（代碼：PTA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241456GlutenID 胶原質基因健康風險檢測Targeted Genomics, LLC K221420AlphaID® 遠端基因健康風險服務Progenika Biopharma S.A., A Grifols Company K192944AncestryDNA 因子V Leiden 遺傳性健康風險測試Ancestry Genomics, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。