FDA 510(k)

E. HISTOLYTICA 快檢

K 號：K170728 · 2017-06-07

決定日期2017-06-07

產品代碼KHW

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

E. HISTOLYTICA QUIK CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K170728. The device is classified under product code KHW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the E. HISTOLYTICA QUIK CHEK?

E. HISTOLYTICA QUIK CHEK is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Techlab, Inc.. The 510(k) number is K170728.

When did E. HISTOLYTICA QUIK CHEK receive FDA 510(k) clearance?

E. HISTOLYTICA QUIK CHEK received FDA 510(k) clearance on 2017-06-07, under 510(k) number K170728.

Who is the listed applicant for E. HISTOLYTICA QUIK CHEK?

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

What is the FDA product code for E. HISTOLYTICA QUIK CHEK?

The FDA product code for E. HISTOLYTICA QUIK CHEK is KHW.

其他以 Techlab, 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。

K191442卡姆披氏菌檢測器 K191456卡姆披氏菌快速檢測 K181379H. PYLORI 快檢 K181400H. PYLORI CHEK™K173217卡姆洛巴菌快檢 K173219卡姆洛巴菌檢測器

查看所有 8 項裝置 →

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。

器材摘要

常見問題

相關臨床試驗

其他以 Techlab, Inc. 為申請人之記錄

官方來源