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FDA 510(k)

膀胱EpiCheck DNA抽提組合包，NX899090-01C，膀胱EpiCheck測試組合包，NX899090-02C，膀胱EpiCheck軟體，NX899090-03C

K 號：K203245 · 2023-05-04

申請人Nucleix , Ltd.
決定日期2023-05-04
產品代碼MMW
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

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C is the device name listed in this FDA 510(k) record. The listed applicant is Nucleix , Ltd.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K203245. The device is classified under product code MMW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Nucleix , Ltd.. The 510(k) number is K203245.

When did Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C receive FDA 510(k) clearance?

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C received FDA 510(k) clearance on 2023-05-04, under 510(k) number K203245.

Who is the listed applicant for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

The FDA 510(k) record lists Nucleix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

The FDA product code for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C is MMW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

官方來源

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