FDA 510(k)

總免疫球蛋白E（IgE）

K 號：K220178 · 2022-03-23

決定日期2022-03-23

產品代碼DGC

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

Total Immunoglobulin E (IgE) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K220178. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Total Immunoglobulin E (IgE)?

Total Immunoglobulin E (IgE) is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K220178.

When did Total Immunoglobulin E (IgE) receive FDA 510(k) clearance?

Total Immunoglobulin E (IgE) received FDA 510(k) clearance on 2022-03-23, under 510(k) number K220178.

Who is the listed applicant for Total Immunoglobulin E (IgE)?

FDA 510(k) 記錄將 Beckman Coulter, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Total Immunoglobulin E (IgE)?

The FDA product code for Total Immunoglobulin E (IgE) is DGC.