FDA 510(k)

葡萄糖HK Gen.3，Gen.2用ISE間接Na，Elecsys TSH，cobas pro整合方案

K 號：K191899 · 2019-08-16

決定日期2019-08-16

產品代碼CFR

諮詢委員會CH

決定相當於

器材摘要

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191899. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions?

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Roche Diagnostics. The 510(k) number is K191899.

When did Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions receive FDA 510(k) clearance?

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191899.

Who is the listed applicant for Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions?

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 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions?

The FDA product code for Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions is CFR.

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

查看所有 69 項裝置 →

相關器械（代碼：CFR）

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。

K253490葡萄糖HK Gen.3；在線數據處理Methadone II；cobas pro整合解決方案Roche Diagnostics K252357葡萄糖2Abbott Ireland K220134cobas pure整合解決方案，葡萄糖HK Gen.3，ISE間接Na for Gen.2，ONLINE DAT美沙鐵II，Elecsys促甲状腺激素Roche Diagnostics K170316ALINITY C 葡萄糖試劑套件，ALINITY C 系統Abbott Laboratories K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I 及 ELITROL IIElitechgroup K151487Diatron Pictus 700 醫學化學分析儀，Diatron ISE，Diatron 葡萄糖己糖激酶法Diatron U.S., 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。