FDA 510(k)

Elecsys Toxo IgM, Elecsys Toxo IgM 精準控制

K 號：K162678 · 2017-06-23

決定日期2017-06-23

產品代碼LGD

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K162678. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Roche Diagnostics. The 510(k) number is K162678.

When did Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl receive FDA 510(k) clearance?

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl received FDA 510(k) clearance on 2017-06-23, under 510(k) number K162678.

Who is the listed applicant for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?

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 Toxo IgM, Elecsys Toxo IgM PreciControl?

The FDA product code for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is LGD.

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：LGD）

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。

K242022Access 痘疹病毒IgGBeckman Coulter, Inc.K242095Access 痘疹病毒IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott Laboratories K210596ARCHITECT Toxo IgGAbbott Laboratories

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