FDA 510(k)

FREND™ 自由T4測試系統

K 號：K152422 · 2016-02-17

決定日期2016-02-17

產品代碼CEC

諮詢委員會CH

決定相當於

器材摘要

FREND™ Free T4 Test System is the device name listed in this FDA 510(k) record. The listed applicant is Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K152422. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FREND™ Free T4 Test System?

FREND™ Free T4 Test System is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K152422.

When did FREND™ Free T4 Test System receive FDA 510(k) clearance?

FREND™ Free T4 Test System received FDA 510(k) clearance on 2016-02-17, under 510(k) number K152422.

Who is the listed applicant for FREND™ Free T4 Test System?

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

What is the FDA product code for FREND™ Free T4 Test System?

The FDA product code for FREND™ Free T4 Test System is CEC.

其他以 Nanoentek USA, 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。

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相關器械（代碼：CEC）

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。

K240273Access自由T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche Diagnostics K182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche Diagnostics K173122Abbott Architect Free T4Abbott Laboratories

官方來源

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