FDA 510(k)

登革熱檢測NS1 ELISA

K 號：K181473 · 2018-08-27

決定日期2018-08-27

產品代碼QCU

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

DENV Detect NS1 ELISA is the device name listed in this FDA 510(k) record. The listed applicant is InBios International, Inc.. It received FDA 510(k) clearance on 2018-08-27 under 510(k) number K181473. The device is classified under product code QCU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DENV Detect NS1 ELISA?

DENV Detect NS1 ELISA is a medical device that received FDA 510(k) clearance on 2018-08-27. The listed applicant is InBios International, Inc.. The 510(k) number is K181473.

When did DENV Detect NS1 ELISA receive FDA 510(k) clearance?

DENV Detect NS1 ELISA received FDA 510(k) clearance on 2018-08-27, under 510(k) number K181473.

Who is the listed applicant for DENV Detect NS1 ELISA?

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

What is the FDA product code for DENV Detect NS1 ELISA?

The FDA product code for DENV Detect NS1 ELISA is QCU.

其他以 InBios International, Inc. 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 InBios International, Inc. 為申請人之記錄

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