FDA 510(k)

IMMULITE® 2000 BR-MA

K 號：K233946 · 2024-03-13

申請人Siemens Healthcare Diagnostics Products, Ltd.

決定日期2024-03-13

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

IMMULITE® 2000 BR-MA is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K233946. 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 IMMULITE® 2000 BR-MA?

IMMULITE® 2000 BR-MA is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K233946.

When did IMMULITE® 2000 BR-MA receive FDA 510(k) clearance?

IMMULITE® 2000 BR-MA received FDA 510(k) clearance on 2024-03-13, under 510(k) number K233946.

Who is the listed applicant for IMMULITE® 2000 BR-MA?

FDA 510(k) 記錄將西门子醫療診斷產品有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for IMMULITE® 2000 BR-MA?

The FDA product code for IMMULITE® 2000 BR-MA is MOI.

其他以 Siemens Healthcare Diagnostics Products, Ltd. 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。

K260331IMMULITE 2000 3g過敏特異性IgE Vantage；IMMULITE 2000 系統花生過敏原（F13）K213510IMMULITE/IMMULITE 1000 OM-MA，IMMULITE 2000 OM-MA K202826IMMULITE® 2000 皮質醇 K203270IMMULITE/IMMULITE® 1000 皮質醇

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.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.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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