FDA 510(k)

LIAISON BRAHMS PCT II GEN，LIAISON Control BRAHMS PCT II GEN，LIAISON BRAHMS PCT II GEN 驗證器

K 號：K173683 · 2018-02-27

決定日期2018-02-27

產品代碼PRI

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2018-02-27 under 510(k) number K173683. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers?

LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers is a medical device that received FDA 510(k) clearance on 2018-02-27. The listed applicant is DiaSorin, Inc.. The 510(k) number is K173683.

When did LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers receive FDA 510(k) clearance?

LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers received FDA 510(k) clearance on 2018-02-27, under 510(k) number K173683.

Who is the listed applicant for LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers?

The FDA product code for LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers is PRI.

其他以 DiaSorin, 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：PRI）

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。

K220262尺寸 EXL LOCI BRAHMS 前鈣蛋白（PCT）Siemens Healthcare Diagnostics, Inc.K192815Elecsys BRAHMS PCTRoche Diagnostics K173927Elecsys BRAHMS PCTRoche Diagnostics K172713Lumipulse G B•R•A•H•M•S PCT 免疫反應芯片，Lumipulse G B•R•A•H•M•S PCT 定標器組Fujirebio Diagnostics,Inc.K170652ARCHITECT B.R.A.H.M.S PCT，ARCHITECT B.R.A.H.M.S PCT 校准劑，ARCHITECT B.R.A.H.M.S PCT 控制劑Fisher Diagnostics K171338B R A H M S PCT 敏感 KRYPTORBrahms GmbH

官方來源

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