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FDA 510(k)

ARCHITECT 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

K 號：K170652 · 2017-06-01

申請人Fisher Diagnostics
決定日期2017-06-01
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

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170652. 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 ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Fisher Diagnostics. The 510(k) number is K170652.

When did ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls receive FDA 510(k) clearance?

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170652.

Who is the listed applicant for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

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

What is the FDA product code for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

The FDA product code for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is PRI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 DiagnosticsK173927Elecsys BRAHMS PCTRoche DiagnosticsK173683LIAISON BRAHMS PCT II GEN，LIAISON Control BRAHMS PCT II GEN，LIAISON BRAHMS PCT II GEN 驗證器DiaSorin, Inc.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.K171338B R A H M S PCT 敏感 KRYPTORBrahms GmbH

官方來源

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