FDA 510(k)

Oragene®•Dx

K 號：K192920 · 2020-01-14

決定日期2020-01-14

產品代碼OYJ

諮詢委員會CH

決定相當於

器材摘要

Oragene®•Dx is the device name listed in this FDA 510(k) record. The listed applicant is DNA Genotek, Inc.. It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K192920. 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 Oragene®•Dx?

Oragene®•Dx is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is DNA Genotek, Inc.. The 510(k) number is K192920.

When did Oragene®•Dx receive FDA 510(k) clearance?

Oragene®•Dx received FDA 510(k) clearance on 2020-01-14, under 510(k) number K192920.

Who is the listed applicant for Oragene®•Dx?

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

What is the FDA product code for Oragene®•Dx?

The FDA product code for Oragene®•Dx is OYJ.

其他以 DNA Genotek, 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。

K254121Colli-Pee•Dx 尿液收集套件 K212745ORAcollect®•Dx K152556Oragene Dx K152464ORAcollect.Dx

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.K192947AncestryDNA 唾液收集套件Ancestry Genomics, Inc.K152556Oragene DxDNA Genotek, Inc.K152464ORAcollect.DxDNA Genotek, Inc.

官方來源

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