FDA 510(k)

Elecsys Cortisol II, Cortisol II CalSet

K 號：K152227 · 2016-04-27

決定日期2016-04-27

產品代碼JFT

諮詢委員會CH

決定相當於

器材摘要

Elecsys Cortisol II, Cortisol II CalSet is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2016-04-27 under 510(k) number K152227. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elecsys Cortisol II, Cortisol II CalSet?

Elecsys Cortisol II, Cortisol II CalSet is a medical device that received FDA 510(k) clearance on 2016-04-27. The listed applicant is Roche Diagnostics. The 510(k) number is K152227.

When did Elecsys Cortisol II, Cortisol II CalSet receive FDA 510(k) clearance?

Elecsys Cortisol II, Cortisol II CalSet received FDA 510(k) clearance on 2016-04-27, under 510(k) number K152227.

Who is the listed applicant for Elecsys Cortisol II, Cortisol II CalSet?

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 Cortisol II, Cortisol II CalSet?

The FDA product code for Elecsys Cortisol II, Cortisol II CalSet is JFT.

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]。K260046Elecsys 抗-HBc II K260049Elecsys 抗-HBc IgM K260048Elecsys 抗-HAV IgM

查看所有 69 項裝置 →

相關器械（代碼：JFT）

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。

K242505Elecsys Cortisol IIIRoche Diagnostics K192788ADVIA Centaur 醞固酮 (COR)Siemens Healthcare Diagnostics, Inc.

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。