FDA PMA

系統，測試，腫瘤標記，用於膀胱癌檢測

PMA 核准號：P940035 · 2022-07-12

決定日期2022-07-12

PMA 編號P940035

產品代碼NAH

器械分類3 類

醫療專科U

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]。

器材摘要

System, test, tumor marker, for detection of bladder cancer is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2022-07-12. The device is classified under product code NAH. It was reviewed by the IM advisory panel.

常見問題

What is the System, test, tumor marker, for detection of bladder cancer?

System, test, tumor marker, for detection of bladder cancer is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Abbott Diagnostics Scarborough, Inc..

When did System, test, tumor marker, for detection of bladder cancer receive FDA 510(k) clearance?

The clearance date for System, test, tumor marker, for detection of bladder cancer can be found in the official FDA records.

Who is the listed applicant for System, test, tumor marker, for detection of bladder cancer?

FDA 510(k) 記錄將 Abbott Diagnostics Scarborough, 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 System, test, tumor marker, for detection of bladder cancer?

The FDA product code for System, test, tumor marker, for detection of bladder cancer is NAH.

官方來源

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