FDA 510(k)

ZEUS IFA™ nDNA測試系統，ZEUS dIFine

K 號：K231616 · 2023-08-31

決定日期2023-08-31

產品代碼KTL

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

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K231616. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Zeus Scientific. The 510(k) number is K231616.

When did ZEUS IFA(TM) nDNA Test System, ZEUS dIFine receive FDA 510(k) clearance?

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231616.

Who is the listed applicant for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

FDA 510(k) 記錄將宙斯科學列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

The FDA product code for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is KTL.

其他以 Zeus Scientific 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。

K261466Alegria Flash MPO；Alegria Flash PR3；Alegria Flash GBM K250814Alegria Flash SSA-60；Alegria Flash SSA-52；Alegria FLash SSB K250666Alegria Flash CTD屏幕 K250408Alegria Flash ENA屏幕 K243776抗中性球胞質抗體（乙醇固定）；抗中性球胞質抗體（福馬林固定）K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 控制組合

查看所有 7 項裝置 →

相關器械（代碼：KTL）

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。

K203599Image Navigator by Immuno Concepts，Immuno Concepts IgG 抗-nDNA 荧光檢測系統Immuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae 套件Inova Diagnostics, Inc.K172244EUROIMMUN IFA：克氏次蟲（抗-dsDNA）EUROPatternEuroimmun Us, Inc.K172252EUROIMMUN IFA：克氏毛蟻蟻敏感（抗-dsDNA）EUROPatternEuroimmun Us, Inc.

官方來源

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