FDA 510(k)

森多薩SA201 HSV 1/2 定性PCR檢測

K 號：K172509 · 2018-02-01

決定日期2018-02-01

產品代碼OQO

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Sentosa SA201 HSV 1/2 Qualitative PCR Test is the device name listed in this FDA 510(k) record. The listed applicant is Vela Diagnostics USA, Inc.. It received FDA 510(k) clearance on 2018-02-01 under 510(k) number K172509. The device is classified under product code OQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sentosa SA201 HSV 1/2 Qualitative PCR Test?

Sentosa SA201 HSV 1/2 Qualitative PCR Test is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Vela Diagnostics USA, Inc.. The 510(k) number is K172509.

When did Sentosa SA201 HSV 1/2 Qualitative PCR Test receive FDA 510(k) clearance?

Sentosa SA201 HSV 1/2 Qualitative PCR Test received FDA 510(k) clearance on 2018-02-01, under 510(k) number K172509.

Who is the listed applicant for Sentosa SA201 HSV 1/2 Qualitative PCR Test?

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

What is the FDA product code for Sentosa SA201 HSV 1/2 Qualitative PCR Test?

The FDA product code for Sentosa SA201 HSV 1/2 Qualitative PCR Test is OQO.

相關器械（代碼：OQO）

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。

K162673Aptima 膜皰病毒 1 & 2 檢測試劑Hologic, Inc.

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OQO）

官方來源