FDA 510(k)

Lumipulse G 25-OH 骨化醇，Lumipulse G 25-OH 骨化醇校准器

K 號：K153361 · 2016-04-15

決定日期2016-04-15

產品代碼MRG

諮詢委員會CH

決定相當於

器材摘要

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators 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 2016-04-15 under 510(k) number K153361. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K153361.

When did Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators receive FDA 510(k) clearance?

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators received FDA 510(k) clearance on 2016-04-15, under 510(k) number K153361.

Who is the listed applicant for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

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 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

The FDA product code for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators is MRG.

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 K192524Lumipulse G CA15-3 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

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相關器械（代碼：MRG）

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。

K232587MAGLUMI 25-OH 膠質D，MAGLUMI X3 全自動化化學發光免疫分析儀Shenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS 维生素D，ALFIS-3 分析儀Immunostics Inc.,K223503Access 25(OH)維生素D總量檢測儀Beckman Coulter, Inc.K210901Elecsys 全部維生素D IIIRoche Diagnostics K200509ADVIA Centaur 全部維生素D (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH 腫島鹼Shenzhen New Industries Biomedical Engineering Co., Ltd.

官方來源

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