FDA 510(k)

葡萄糖HK Gen.3；在線數據處理Methadone II；cobas pro整合解決方案

K 號：K253490 · 2026-02-12

決定日期2026-02-12

產品代碼CFR

諮詢委員會CH

決定相當於

器材摘要

Glucose HK Gen.3; ONLINE DAT Methadone II; 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 2026-02-12 under 510(k) number K253490. 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; ONLINE DAT Methadone II; cobas pro integrated solutions?

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Roche Diagnostics. The 510(k) number is K253490.

When did Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions receive FDA 510(k) clearance?

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253490.

Who is the listed applicant for Glucose HK Gen.3; ONLINE DAT Methadone II; 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; ONLINE DAT Methadone II; cobas pro integrated solutions?

The FDA product code for Glucose HK Gen.3; ONLINE DAT Methadone II; 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

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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。

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 K191899葡萄糖HK Gen.3，Gen.2用ISE間接Na，Elecsys TSH，cobas pro整合方案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

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