FDA 510(k)

人類IgM試劑，適用於SPAPlus

K 號：K191465 · 2019-06-27

決定日期2019-06-27

產品代碼CFN

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

Human IgM Kit for use on SPAPlus is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K191465. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Human IgM Kit for use on SPAPlus?

Human IgM Kit for use on SPAPlus is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K191465.

When did Human IgM Kit for use on SPAPlus receive FDA 510(k) clearance?

Human IgM Kit for use on SPAPlus received FDA 510(k) clearance on 2019-06-27, under 510(k) number K191465.

Who is the listed applicant for Human IgM Kit for use on SPAPlus?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Human IgM Kit for use on SPAPlus?

The FDA product code for Human IgM Kit for use on SPAPlus is CFN.

其他以 The Binding Site Group , Ltd. 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。

K250159免疫球蛋白同種型（GAM）用於EXENT分析儀；EXENT分析儀 K250549Optilite® Freelite Mx Kappa Free 套件；Optilite® Freelite Mx Lambda Free 套件 K192116人類IgA液態試劑套件，適用於SPAPlus K191985Optilite IgA 套件 K191635Optilite IgM 套件 K190686Optilite IgM CSF 套件

查看所有 17 項裝置 →

相關器械（代碼：CFN）

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。

K233663N 人免疫球蛋白（IgG、IgA 及 IgM）抗血清Siemens Healthcare Diagnostics Products GmbH K221114免疫球蛋白G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116人類IgA液態試劑套件，適用於SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA 套件The Binding Site Group , Ltd.K191635Optilite IgM 套件The Binding Site Group , Ltd.K190686Optilite IgM CSF 套件The Binding Site Group , Ltd.

官方來源

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