FDA 510(k)

Beta-2微球蛋白

K 號：K161297 · 2016-06-07

決定日期2016-06-07

產品代碼JZG

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

Beta-2-Microglobulin is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K161297. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Beta-2-Microglobulin?

Beta-2-Microglobulin is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K161297.

When did Beta-2-Microglobulin receive FDA 510(k) clearance?

Beta-2-Microglobulin received FDA 510(k) clearance on 2016-06-07, under 510(k) number K161297.

Who is the listed applicant for Beta-2-Microglobulin?

The FDA 510(k) record lists Beckman Coulter Ireland, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Beta-2-Microglobulin?

The FDA product code for Beta-2-Microglobulin is JZG.

其他以 Beckman Coulter Ireland, Inc. 為申請人之記錄

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K182651HbA1c先進版 K161508銅藍蛋白

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