FDA 510(k)

Lumipulse G E2-III 校正器

K 號：K163053 · 2016-12-01

決定日期2016-12-01

產品代碼JIT

諮詢委員會CH

決定相當於

器材摘要

Lumipulse G E2-III 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 2016-12-01 under 510(k) number K163053. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lumipulse G E2-III Calibrators?

Lumipulse G E2-III Calibrators is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K163053.

When did Lumipulse G E2-III Calibrators receive FDA 510(k) clearance?

Lumipulse G E2-III Calibrators received FDA 510(k) clearance on 2016-12-01, under 510(k) number K163053.

Who is the listed applicant for Lumipulse G E2-III 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 E2-III Calibrators?

The FDA product code for Lumipulse G E2-III Calibrators is JIT.

其他以 Fujirebio 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。

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：JIT）

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。

K171168維特羅斯免疫診斷產品胰島素校准器Ortho Clinical Diagnostics K170938CalSet IGF-1Roche Diagnostics K170160Abbott ARCHITECT Free T3Abbott Laboratories K163546Lumipulse G 孕酮-N 校准器Fujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N 校正器Fujirebio Diagnostics,Inc.K163544Lumipulse G 乳糖素Fujirebio Diagnostics,Inc.

官方來源

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