FDA 510(k)

免疫球蛋白同種型（GAM）用於EXENT分析儀；EXENT分析儀

K 號：K250159 · 2025-10-17

決定日期2025-10-17

產品代碼SGG

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

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser 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 2025-10-17 under 510(k) number K250159. The device is classified under product code SGG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K250159.

When did Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser receive FDA 510(k) clearance?

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250159.

Who is the listed applicant for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

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 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

The FDA product code for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is SGG.

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。

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 K191465人類IgM試劑，適用於SPAPlus K190686Optilite IgM CSF 套件

查看所有 17 項裝置 →

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。