FDA 510(k)

Hevylite 人類IgG Kappa Kit，適用於SPAPLUS，Hevylite 人類IgG Lambda Kit，適用於SPAPLUS

K 號：K161854 · 2016-10-04

決定日期2016-10-04

產品代碼PCN

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

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the 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 2016-10-04 under 510(k) number K161854. The device is classified under product code PCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K161854.

When did Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS receive FDA 510(k) clearance?

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161854.

Who is the listed applicant for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the 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 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

The FDA product code for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is PCN.

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。

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查看所有 17 項裝置 →

相關器械（代碼：PCN）

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。

K172613Optilite Hevylite IgG Kappa 套件，Optilite Hevylite IgG Lambda 套件The Binding Site Group , Ltd.

官方來源

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