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FDA 510(k)

Lumipulse G TSH-III 適應反應芯片

K 號：K171103 · 2017-07-28

申請人Fujirebio Diagnostics,Inc.
決定日期2017-07-28
產品代碼JLW
諮詢委員會CH
決定相當於

器材摘要

Lumipulse G TSH-III Immunoreaction Cartridges 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 2017-07-28 under 510(k) number K171103. 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 Lumipulse G TSH-III Immunoreaction Cartridges?

Lumipulse G TSH-III Immunoreaction Cartridges is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K171103.

When did Lumipulse G TSH-III Immunoreaction Cartridges receive FDA 510(k) clearance?

Lumipulse G TSH-III Immunoreaction Cartridges received FDA 510(k) clearance on 2017-07-28, under 510(k) number K171103.

Who is the listed applicant for Lumipulse G TSH-III Immunoreaction Cartridges?

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 TSH-III Immunoreaction Cartridges?

The FDA product code for Lumipulse G TSH-III Immunoreaction Cartridges is JLW.

相關臨床試驗

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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。

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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。

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官方來源

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