FDA 510(k)

AncestryDNA 唾液收集套件

K 號：K192947 · 2020-08-13

決定日期2020-08-13

產品代碼OYJ

諮詢委員會CH

決定相當於

器材摘要

AncestryDNA Saliva Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ancestry Genomics, Inc.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K192947. The device is classified under product code OYJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AncestryDNA Saliva Collection Kit?

AncestryDNA Saliva Collection Kit is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Ancestry Genomics, Inc.. The 510(k) number is K192947.

When did AncestryDNA Saliva Collection Kit receive FDA 510(k) clearance?

AncestryDNA Saliva Collection Kit received FDA 510(k) clearance on 2020-08-13, under 510(k) number K192947.

Who is the listed applicant for AncestryDNA Saliva Collection Kit?

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

What is the FDA product code for AncestryDNA Saliva Collection Kit?

The FDA product code for AncestryDNA Saliva Collection Kit is OYJ.

其他以 Ancestry Genomics, Inc. 為申請人之記錄

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。

K192944AncestryDNA 因子V Leiden 遺傳性健康風險測試

相關器械（代碼：OYJ）

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。

K212745ORAcollect®•DxDNA Genotek, Inc.K192920Oragene®•DxDNA Genotek, Inc.K152556Oragene DxDNA Genotek, Inc.K152464ORAcollect.DxDNA Genotek, Inc.

官方來源

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