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FDA 510(k)

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）

K 號：K243570 · 2025-04-25

申請人Siemens Healthcare Diagnostics
決定日期2025-04-25
產品代碼JLW
諮詢委員會CH
決定相當於

器材摘要

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243570. 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 Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)?

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K243570.

When did Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) receive FDA 510(k) clearance?

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243570.

Who is the listed applicant for Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)?

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

What is the FDA product code for Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)?

The FDA product code for Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) is JLW.

相關臨床試驗

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其他以 Siemens Healthcare Diagnostics 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。

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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.K234091Maverick診斷系統TC1000; Maverick測試面板A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, 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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