FDA 510(k)

Lumipulse G CA15-3

K 號：K192524 · 2020-09-04

決定日期2020-09-04

產品代碼MOI

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

Lumipulse G CA15-3 is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K192524. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lumipulse G CA15-3?

Lumipulse G CA15-3 is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K192524.

When did Lumipulse G CA15-3 receive FDA 510(k) clearance?

Lumipulse G CA15-3 received FDA 510(k) clearance on 2020-09-04, under 510(k) number K192524.

Who is the listed applicant for Lumipulse G CA15-3?

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

What is the FDA product code for Lumipulse G CA15-3?

The FDA product code for Lumipulse G CA15-3 is MOI.

其他以 Fujirebio Diagnostics,Inc. 為申請人之記錄

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K250925ADVIA Centaur 維甲酸片段 21-1 K242706Lumipulse G pTau217/β-Amyloid 1-42 血漿比值 K192380ST AIA-PACK BNP 注意：此翻譯僅根據給定的政策進行，並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。K200997Lumipulse G CA19-9-N K190702Lumipulse G 全部 PTH K172713Lumipulse G B•R•A•H•M•S PCT 免疫反應芯片，Lumipulse G B•R•A•H•M•S PCT 定標器組

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相關器械（代碼：MOI）

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。

K240403Access BR 監控儀Beckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche Diagnostics K171605Elecsys CA 15-3 IIRoche Diagnostics

官方來源

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