FDA 510(k)

Elecsys FT4 IV

K 號：K220456 · 2023-04-07

決定日期2023-04-07

產品代碼CEC

諮詢委員會CH

決定相當於

器材摘要

Elecsys FT4 IV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K220456. 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 Elecsys FT4 IV?

Elecsys FT4 IV is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Roche Diagnostics. The 510(k) number is K220456.

When did Elecsys FT4 IV receive FDA 510(k) clearance?

Elecsys FT4 IV received FDA 510(k) clearance on 2023-04-07, under 510(k) number K220456.

Who is the listed applicant for Elecsys FT4 IV?

FDA 510(k) 記錄將羅氏醫學診斷列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Elecsys FT4 IV?

The FDA product code for Elecsys FT4 IV is CEC.

其他以 Roche Diagnostics 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。

K261686Elecsys 磷酸鐵蛋白-Tau (217P) 血漿 K252323cobas pulse 血糖監測系統 K252280Elecsys Anti-SARS-CoV-2 S 醫療設備規範文本 Elecsys Anti-SARS-CoV-2 S 醫療設備，已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的NCT編號為[識別號]，PMID編號為[識別號]。請參考以下URL獲取更多資訊：[URL]。K260049Elecsys 抗-HBc IgM K260048Elecsys 抗-HAV IgM K260046Elecsys 抗-HBc II

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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.K182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche Diagnostics K173122Abbott Architect Free T4Abbott Laboratories K152422FREND™ 自由T4測試系統Nanoentek USA, Inc.

官方來源

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