FDA 510(k)

ADVIA Centaur® TSH3-Ultra II (TSH3ULII)

K 號：K233050 · 2024-04-04

決定日期2024-04-04

產品代碼JLW

諮詢委員會CH

決定相當於

器材摘要

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K233050. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur® TSH3-Ultra II (TSH3ULII)?

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K233050.

When did ADVIA Centaur® TSH3-Ultra II (TSH3ULII) receive FDA 510(k) clearance?

ADVIA Centaur® TSH3-Ultra II (TSH3ULII) received FDA 510(k) clearance on 2024-04-04, under 510(k) number K233050.

Who is the listed applicant for ADVIA Centaur® TSH3-Ultra II (TSH3ULII)?

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

What is the FDA product code for ADVIA Centaur® TSH3-Ultra II (TSH3ULII)?

The FDA product code for ADVIA Centaur® TSH3-Ultra II (TSH3ULII) is JLW.

其他以 Siemens Healthcare Diagnostics, Inc. 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。

K253528Atellica IM CA 19-9 II K261364Atellica CH 阿斯匹林 2 (ACTM)K251998Atellica CH 碘化物總膽紅素 (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM 全部前列腺特异性抗原 II (tPSAII)K250816ADVIA Centaur 抗甲状腺球蛋白II (aTgII)

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相關器械（代碼：JLW）

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。

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570維度LOCI 促甲状腺激素Flex試劑卡（TSHL）；維度LOCI 游離甲状腺素Flex試劑卡（FT4L）Siemens Healthcare Diagnostics K234091Maverick診斷系統TC1000; Maverick測試面板A0.B0Genalyte, Inc.K222116Atellica® CI 分析儀, Atellica® IMThyroid 刺激激素 3-Ultra (TSH3-UL), Atellica® CH 白蛋白 BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225AccessTSH（第3個IS）測試，DxI 9000Access免疫測定分析儀Beckman Coulter, Inc.K190773Elecsys TSHRoche Diagnostics

官方來源

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